[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-olympus-medical-systems-corporation-729208-10072026":3,"fda-latest-sync-dates":28},{"id":4,"letter_id":5,"action_type":6,"firm_name":7,"fei_number":8,"issuing_office":9,"subject":10,"posted_date":11,"action_taken_date":12,"response_letter_date":8,"closeout_date":8,"case_status":13,"letter_url":14,"reference_number":8,"marcs_cms_no":15,"product_type":16,"delivery_method":17,"recipient_name":8,"recipient_title":8,"body_html":18,"body_text":19,"body_fetched_at":20,"medical_device_id":8,"raw":21,"created_at":26,"updated_at":27},21920,"olympus-medical-systems-corporation-729208-10072026","Warning Letter","Olympus Medical Systems Corporation",null,"Center for Devices and Radiological Health","CGMP\u002FQSR\u002FMedical Devices\u002FAdulterated","2026-10-20","2026-10-07","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Folympus-medical-systems-corporation-729208-10072026","729208","Medical Devices","VIA Electronic Mail","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n  \u003Chr>\n \n\n\u003Cdiv>\n  \u003Cdl>\n\n              \u003Cdt>Delivery Method:\u003C\u002Fdt> \n        \u003Cdd>VIA Electronic Mail\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n      \n              \u003Cdt>Product:\u003C\u002Fdt> \n        \u003Cdd>Medical Devices                          \n            \n            \n            \n            \n            \n            \n            \n             \n            \n            \n            \n              \n            \n            \n            \u003C\u002Fdd>\n      \n          \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n\n\u003Chr>\n\n\u003Cdiv>\n  \u003Cdiv>\n    \u003Cdl>\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\u003C\u002Fdd>\n                    \n            \u003Cdd>Olympus Medical Systems Corporation\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp>\u003Cspan>2951 Ishikawa-machi\u003C\u002Fspan>\u003Cbr>\n\u003Cspan>Hachioji-shi\u003C\u002Fspan>, \u003Cspan>Tokyo\u003C\u002Fspan>\u003Cbr>\n\u003Cspan>192-8507\u003C\u002Fspan>\u003Cbr>\n\u003Cspan>Japan\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n            \n            \u003Cdd>\n\n    \u003C\u002Fdd>\u003Cdd>\u003Cspan>\u003C\u002Fspan>\u003Ca href=\"mailto:(b)(6)@olympus.com\"> (b)(6)@olympus.com\u003C\u002Fa>\u003C\u002Fdd>\n\n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv>\n    \u003Cdl>\n          \n          \u003Cdt>Issuing Office:\u003C\u002Fdt>\n        \n         \n          \u003Cdd>Center for Devices and Radiological Health\u003C\u002Fdd>\n        \n         \n          \u003Cdd>\u003Cp>\u003Cspan>United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n        \n        \n        \n        \n        \n    \u003C\u002Fdl>\n    \u003Cdl> \n      \n  \u003Cdiv>\n    \u003Cdiv>Secondary Issuing Offices\u003C\u002Fdiv>\n          \u003Cdiv>\n              \u003Cdiv>    \u003Cbr>\n    \n     \n        \u003Cdd>\u003Cp>\u003Cspan>United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n    \n    \n    \n    \n\u003C\u002Fdiv>\n              \u003C\u002Fdiv>\n      \u003C\u002Fdiv>\n\n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp>\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003Cbr>CMS #729208\u003C\u002Fp>\u003Cp>October 7, 2026\u003C\u002Fp>\u003Cp>Dear Mr. White:\u003C\u002Fp>\u003Cp>The United States Food and Drug Administration (FDA) conducted the following inspections of your firm’s medical device facilities:\u003C\u002Fp>\u003Cul>\u003Cli>Olympus Medical Systems Corporation, located at 2951 Ishikawa-Cho, Hachioji-Shi, Tokyo, JP 192-8507, FEI 3002807795, November 17, 2025, to November 21, 2025 (“Hachioji”)\u003C\u002Fli>\u003Cli>Aomori Olympus Co., Ltd., located at 2-248-1 Okkonoki, Kuroishi-shi, Aomori, JP, 036-0357, FEI 3003995201, from November 4, 2025, to November 7, 2025 (“Aomori”)\u003C\u002Fli>\u003Cli>Olympus Medical Systems Corp. Hinode Plant, located at 34-3 Hirai, Hinode-Machi, Nishitama-Gun, Tokyo, JP, 190-0182, FEI 3003637092, from November 17, 2025, to November 21, 2025 (“Hinode”)\u003C\u002Fli>\u003Cli>Shirakawa Olympus Co., Ltd., located at 3-1 Okamiyama, Odakura, Nishigo-Mura, Nishishirakawa-Gun, Fukushima, JP 961-8061, FEI 3002808148, November 10, 2025, to November 14, 2025 (“Shirakawa”)\u003C\u002Fli>\u003Cli>Olympus Winter & IBE Gmbh, located at Kuehnstrasse 61, Hamburg, DE 22045, FEI 3002807798, from November 10, 2025, to November 21, 2025 (“Hamburg”)\u003C\u002Fli>\u003Cli>Gyrus ACMI, Inc. [dba Olympus Surgical Technologies (OSTA)], located at 9600 Louisiana Ave North, Brooklyn Park, MN 55445, FEI 3011050570, from October 6, 2025, to November 12, 2025 (“Brooklyn Park”)\u003C\u002Fli>\u003C\u002Ful>\u003Cp>During these inspections, our investigators determined that your firm manufactures a variety of surgical and endotherapy devices, including but not limited to, hemostatic metal clips, sphincterotomes, cystoscopes, bronchoscopes, endoscopic distal covers, valves, and insufflators. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.\u003C\u002Fp>\u003Cp>\u003Cstrong>\u003Cu>Quality System Regulation Violations\u003C\u002Fu>\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>The above-referenced inspections revealed that the devices manufactured at the Hachioji, Aomori, Hinode, Shirakawa, Hamburg, and Brooklyn Park facilities are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. This nonconformity includes issues across the referenced inspected facilities, resulting in the distribution of nonconforming devices and significant risks to patients.\u003C\u002Fp>\u003Cp>A Form FDA 483 (FDA 483), List of Inspectional Observations, was issued to the Aomori facility on November 7, 2025, the Brooklyn Park facility on November 12, 2025, the Shirakawa facility on November 14, 2025, the Hachioji facility on November 21, 2025, the Hinode facility on November 21, 2025, and the Hamburg facility on November 21, 2025. We received responses concerning our investigator’s observations noted on these FDA 483s from Robert A. Fryc, Director, Global Quality Compliance, External Regulatory Communications, Olympus Corporation of the Americas, dated December 22, 2025, February 13, 2026, March 30, 2026, May 28, 2026, and July 31, 2026. We address these responses (collectively referred to as “your firm’s response”) below, in relation to each of the noted violations. These violations include, but are not limited to, the following:\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cu>Design Control Violations – Shirakawa, Aomori, Hamburg, and Hachioji facilities\u003C\u002Fu>\u003C\u002Fem>\u003C\u002Fp>\u003Cp>1. Failure to establish and maintain procedures for validating the device design to ensure that devices conform to defined user needs and intended uses and validation shall include testing of production units under actual or simulated use conditions, as required by 21 CFR 820.30(g). For example,\u003C\u002Fp>\u003Cp>a. At the Shirakawa facility, your firm failed to identify and control known catastrophic hazards in your risk management documentation and failed to validate the device design under actual or simulated use conditions for the UHI-4 insufflator. Catastrophic hazards, including air embolism, arrhythmia, and patient death, were identified through Health Hazard Assessments and complaint investigations associated with CAPA-201353; however, your \u003Cem>Risk Management Report\u003C\u002Fem> (DC00067142, dated November 6, 2025) did not reflect these hazards or ensure implementation of appropriate risk control measures, even after a confirmed patient death and Class I recall of UHI-4 units in 2023. Further, your design validation did not simulate actual or worst-case use conditions related to pressure sensor failure or inaccurate pressure measurements to ensure that the device would operate safely. As a result, devices distributed had design deficiencies that contributed to overpressure events during clinical use.\u003C\u002Fp>\u003Cp>The adequacy of your firm’s response cannot be determined. Your response states that design-related deficiencies are being addressed through global CAPAs, including CAPA-204150 (design control) and CAPA-203525 (risk management), and that a traceability matrix for the UHI-4 will be developed to evaluate design requirements, verification, and validation. You also indicate that additional design verification and\u002For validation testing will be performed as needed and that potential design changes will be assessed by the design owner (Olympus Hachioji). However, these activities remain ongoing, and you have not provided objective evidence demonstrating that design validation deficiencies have been corrected or that revised validation activities adequately address identified risks, including overpressure conditions. Additionally, corrective actions have been deferred to global CAPAs and another facility, and no documentation has been provided demonstrating completion or effectiveness of these actions.\u003C\u002Fp>\u003Cp>b. At the Aomori facility, your firm failed to identify and assess known hazards in the risk management documentation and failed to establish risk control measures for manufacturing processes for the Sphincterotome. In your risk management report (E_V-KD_\u003Cem>Risk Management Report\u003C\u002Fem>_Rev.27), the corresponding risk line ID (KD-G158-00) identifies the potential patient harm as “Delay in Treatment” for complaints of deformed wires but fails to include the higher risk identified through analysis of Medical Device Reports of unintended cutting of blood vessels leading to patient bleeding. It also fails to identify any risk control measures for the manufacture of the wire for the Sphincterotome. Additionally, the risk management report (DC00609260_20250910) does not include the known hazard of failure of the Automated Optical Inspection system to detect nonconforming Sphincterotome products (KD-V400 Series) with burrs and flakes and does not include risk control measures for this hazard, which can lead to tissue damage and procedural complications.\u003C\u002Fp>\u003Cp>The adequacy of your firm’s response cannot be determined at this time. Your firm has not provided an updated \u003Cem>Risk Management Report\u003C\u002Fem> (DC00609260_20250910) to address the hazard and implement risk control measures for failure of the Automated Optical Inspection system to detect nonconforming Sphincterotome products (KD-V400 Series) with burrs and flakes. Additionally, your firm has not provided an updated risk management report (E_V-KD_\u003Cem>Risk Management Report\u003C\u002Fem>) to address the risk of unintended cutting of blood vessels leading to patient bleeding and risk control measures for manufacture of the wire.\u003C\u002Fp>\u003Cp>c. At the Hamburg facility, your firm distributed the Continuous Flow Cystoscope (model WA22810A) with instructions for use (IFU) that claimed compatibility with the GreenLight PV ADDstat laser fiber component without conducting design validation testing to ensure compatibility under use conditions. This resulted in two recalls, RES 95584 and RES 98300, due to a risk of damage and\u002For overheating to the tip of the sheath when used together. Unrecognized sheath damage can result in tissue injury or parts of the sheath breaking off into the patient.\u003C\u002Fp>\u003Cp>The adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. Your response should include a retrospective review of similar devices with IFU compatibility claims to ensure that they are supported by design validation activities to ensure compatibility under use conditions.\u003C\u002Fp>\u003Cp>d. At the Hachioji facility:\u003C\u002Fp>\u003Cp>i. Your firm distributed the BF-1TH190 bronchoscope with instructions for use (IFU) claiming compatibility with CO\u003Csub>2\u003C\u002Fsub> lasers without conducting design validation testing to ensure compatibility under use conditions. This resulted in a class I recall (RES 93052), due to a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen and\u002For the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope. If endobronchial combustion occurs, the patient may suffer adverse events, including internal burns in their airway or lungs. The related CAPA did not evaluate compatibility claims for all endoscopes and lasers.\u003C\u002Fp>\u003Cp>ii. Design validation activities were not conducted with an understanding of the actual operating conditions for the Evis Exera Video Imaging System, used with your firm’s endoscopes for processing images. For example, design validation did not consider the conductivity of the electrolyte when it contained dust and moisture, nor did it consider the impact over time of water entering the scope during cleaning. This caused signal transmission problems and resulted in a significant number of complaints and MDRs for image erasure, image transition problems, and poor-quality images.\u003C\u002Fp>\u003Cp>iii. Your firm failed to complete design verification testing after implementing a change to the 0.2 μm Water Filter (Part MAJ-2318) to demonstrate that the device meets established design requirements and acceptance criteria. This water filter is used in your OER-Elite and OER-Mini Reprocessors for cleaning and high-level disinfection of your flexible endoscopes, their accessories, and endoscope reprocessor accessories. Your firm’s design change control procedure, OMBS_S_7.3.9_01_001, requires design verification or validation for all changes. However, ECR ER00006389 (dated December 11, 2024) shows verification testing was incomplete. Document MAJ-318_DC00429244 establishes the requirements and acceptance criteria for the product, including a filter service life of at least one month; however, design verification and validation records did not demonstrate that the filter has a service life of at least one month.\u003C\u002Fp>\u003Cp>iv. Your firm’s design change control procedure, OMBS_S_7.3.9_01_001, and \u003Cem>Traceability Activities\u003C\u002Fem> (OMBS W_7.3.3_03_002) require documentation of design traceability matrices. However, you have not implemented design traceability matrices for the following products: Evis Exera III Bronchovideoscopes, Evis Exera III Video System Center, Evis X1 Video System Center, Single Use Reloadable Clip Applicator, Endoscope Reprocessor, Evis Exera III Duodenovideoscopes. Without design traceability matrices there is no documentation demonstrating that all design requirements, including safety requirements, were properly verified and validated.\u003C\u002Fp>\u003Cp>The adequacy of your firm’s response for (i) through (iv) above cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness.\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cu>Nonconforming Product Violations – Brooklyn Park and Hinode facilities:\u003C\u002Fu>\u003C\u002Fem>\u003C\u002Fp>\u003Cp>2. Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). For example,\u003C\u002Fp>\u003Cp>a. At the Brooklyn Park facility,\u003C\u002Fp>\u003Cp>i. Your firm reworked and distributed nonconforming Vizishot 2 FLEX (19G) devices without adequate justification that the rework addressed the cause of the nonconformance. NCR-00038111 was opened on July 30, 2025, to disposition nonconforming material subject to recall (RES 97303) for the detachment of the Vizishot 2 Flex 19G needle [laser cut hypotube (LCH)] after reported complaints and MDRs, including where the device may have contributed to a patient death during explant surgery to recover the detached needle. Your firm reworked product under NCR-00038111 and dispositioned passing products using an automated vision system for release, stating this minimized impact on any product safety, efficacy, or performance of the product\u002Fmaterial. However, the primary CAPA for the LCH ejection issues had not identified a root cause, and there were two additional CAPAs open related to the observed complaints (pebax material degradation and sheath snap lock not engaging), indicating other potential contributing factors to nonconformances. Additionally, your firm circumvented the ship hold in place under the NCR by changing the manufacturing date during rework, which allowed the release of those units.\u003C\u002Fp>\u003Cp>The adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. CAPA-203864 was opened and determined that the issue was linked to global processes GSOP‑00022 \u003Cem>Global NC Management\u003C\u002Fem> and GSOP‑00023 \u003Cem>Global CAPA Management\u003C\u002Fem>. The process related aspects of this observation are being addressed separately under Global CAPAs, CAPA-203799 and CAPA-204047. Your response acknowledged in CAPA 203864 that the eleven lots of product noted in NCR-00038111 underwent rework outside of your procedures. You reinstated the ship hold and quarantined all Vizishot 2 FLEX product. You executed product removal activities separately for Vizishot 2 FLEX (19G) devices, including a global removal decision made on December 11, 2025, with a corresponding 806 report submitted to FDA. Your firm’s corrective actions are ongoing under CAPA-203864, CAPA-203799 and CAPA-204047.\u003C\u002Fp>\u003Cp>ii. Your firm failed to control all nonconforming Shockpulse Lithotripsy generators that were subject to recall due to a miswired component (RES 98360). NCR-00000670 was opened on June 1, 2022, to scope the units affected under recall FY23-OSTA-05, for the miswiring of the Shockpulse generator. This NCR did not include a scope of all affected devices, including 2 lots containing 21 and 25 sub-assemblies, 9 finished units, and 2 service units. NCR-00046008 was opened to address the scoping nonconformance.\u003C\u002Fp>\u003Cp>The adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. CAPA-203777 was opened and the root cause identified the need to evaluate process gaps in \u003Cem>Global Nonconformance Management\u003C\u002Fem> GSOP-00022, specifically related to scoping methodology, alignment with HHA\u002FFCA teams, and decision-making during NCR and Stop Ship activities. A Global Ship Hold for miswired ShockPulse generator units was initiated on November 12, 2025, and the recall scope was expanded on December 9, 2025, with an 806 report submitted to FDA. Your firm’s corrective actions are ongoing under CAPA-203777 and CAPA-204047.\u003C\u002Fp>\u003Cp>b. At the Hinode facility,\u003C\u002Fp>\u003Cp>i. Your firm failed to control nonconforming MAJ 210 single-use biopsy valves when devices failed durability testing during the investigation of CAPA 203270. This CAPA was initiated after receiving multiple complaints reporting fractures of the device, including MDR reportable events. Although devices failed testing during the complaint investigation, your firm did not initiate a nonconformance for these out-of-specification device failures. Your firm eventually initiated NCR-00030581 for the complaint trend, but not for the identified testing failures.\u003C\u002Fp>\u003Cp>We reviewed your firm’s response and determined that it is not adequate. Your firm has initiated actions to address the MAJ-210 failures, including a shipping hold on the device, a plan to modify the device design, and an investigation into the complaint trend. Your response does not address why a nonconformance was not initiated when testing showed the product\u002Ffailed the durability specification per GSOP-00029 \u003Cem>Global Complaint Investigation\u003C\u002Fem> and was only later opened for the complaint trend. It is unclear if you plan to evaluate whether similar issues occurred for other devices and how you will ensure that complaint investigations result in CAPAs when appropriate.\u003C\u002Fp>\u003Cp>ii. Your firm failed to control nonconforming devices with sterile barrier seal overlap defects that were found to impact seal integrity. A nonconformance (NCR-00025684) was initiated in March 2025 in response to observed defects in sterile seals from September 2024- January 2025. NCR-00025684 identified overlaps as a novel defect that was not included in your visual inspection procedures. CAPA-202690 concluded that because seal overlaps are a large wrinkle, inspectors trained to visually identify wrinkles would identify seal overlap defects. However, wrinkles and seal overlaps represent distinct sterile barrier defects. CAPA-203907 included a retrospective evaluation to demonstrate that existing visual inspection procedures were likely to identify seal overlaps, based on a blind test of engineers. However, this evaluation does not demonstrate that overlaps were identified at the time of the nonconformances.\u003C\u002Fp>\u003Cp>We reviewed your firm’s response and determined that it is not adequate. You state that you are conducting an investigation and root cause analysis as part of your CAPA; however, this is in progress and the details of this investigation and corrective actions are not clear, and you have not yet provided objective evidence demonstrating completion or effectiveness.\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cu>Production and Process Controls Violations – Brooklyn Park, Hinode, Aomori, and Shirakawa facilities\u003C\u002Fu>\u003C\u002Fem>\u003C\u002Fp>\u003Cp>3. Failure to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a). For example,\u003C\u002Fp>\u003Cp>a. At the Brooklyn Park facility,\u003C\u002Fp>\u003Cp>i. Your firm failed to validate the heat sealing process for the \u003Cstrong>(b)(4)\u003C\u002Fstrong> Tray Sealer. The \u003Cstrong>(b)(4)\u003C\u002Fstrong> Tray Sealer (P4001467-001 Gyrus ACMI SN:01) Operational Qualification using Universal tray sealing nests, documented in \u003Cem>Operational Qualification (OQ) Report\u003C\u002Fem> D8201348-002 Rev AB, does not contain passing results for the challenge conditions at the high and low setpoints. The validation was intended to cover low setpoints of 200°F, 100 PSI, and 2.0 seconds and high setpoints of 265°F, 125 PSI, and 7.0 seconds. However, visual results showed all failures at the lower setpoints and all failures at the high setpoints for the Universal and PKS Omni products. Only the nominal settings (232°F, 115 PSI, 4.5 seconds) showed passing results, which do not match your current production setpoints (253°F, 118 PSI, 4 seconds).\u003C\u002Fp>\u003Cp>During the inspection, you re-executed the validation (D8201348-002, Revision AC). While this validation passed seal integrity and seal strength requirements at high and low challenge conditions, the deviation section notes that trays sealed at low settings had spottiness in the seal and trays from high settings had warp that would cause rejection during 100% visual inspection, demonstrating that the process is not capable of consistently producing conforming product throughout the acceptable setpoint ranges.\u003C\u002Fp>\u003Cp>The adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. You are in the process of implementing CAPA-203841 to address the root cause of inadequate process for assessing procedure revisions that resulted in earlier validations (Operational Qualifications) not being updated to meet regulatory requirements. Specifically, you plan to transition from \u003Cem>Process Validation\u003C\u002Fem> GSOP-7.5-1 to \u003Cem>Global Process Validation\u003C\u002Fem> GSOP-00002. Your response indicates that the retrospective re-validation of the heat sealers is complete except for the \u003Cstrong>(b)(4)\u003C\u002Fstrong> sealer for the Universal Tray products and the \u003Cstrong>(b)(4)\u003C\u002Fstrong> sealer for the Powerseal vessel sealing product line. You are currently assessing the risks associated with products manufactured and distributed using the \u003Cstrong>(b)(4)\u003C\u002Fstrong> Tray Sealer, which failed the retrospective re-validation. Regarding the retrospective revalidation of the \u003Cstrong>(b)(4)\u003C\u002Fstrong> heat sealer used for the Powerseal product line you have noted the OQ failed to meet seal width acceptance criteria as detailed in the protocol, however, the OQ\u002FPQ testing will not be repeated at the current process settings (temperature, time, pressure). You have indicated that you will communicate with FDA regarding any actions taken based on the outcome of the completed HHA for distributed product and failed retrospective revalidation.\u003C\u002Fp>\u003Cp>ii. Your firm failed to validate the heat sealing process for tray material PN0003356 (45cm PETG Tray line) on the \u003Cstrong>(b)(4)\u003C\u002Fstrong> sealer SN01. The \u003Cem>OQ Report for \u003Cstrong>(b)(4)\u003C\u002Fstrong> BM3025-E2W2 for 45cm packaging\u003C\u002Fem> (DN0010012) and \u003Cem>PQ Report for BP \u003Cstrong>(b)(4)\u003C\u002Fstrong> BM3025-E2W2 for 45cm packaging\u003C\u002Fem> (DN0010301) for this material and setpoints is for sealer \u003Cstrong>(b)(4)\u003C\u002Fstrong>, which was decommissioned and removed from use in 2023. Your firm did not provide documentation showing this material was validated on the \u003Cstrong>(b)(4)\u003C\u002Fstrong> sealer or justification for equipment equivalency.\u003C\u002Fp>\u003Cp>In addition, your procedure \u003Cem>Process Confirmation for Sterile Barrier Sealing\u003C\u002Fem> GWI-0704-07 Rev AE dated April 4, 2024, allows for abbreviated validation runs for \"equivalent or duplicate equipment.\" This procedure allows for equipment with the same manufacturer and model number to be considered equivalent, regardless of the year purchased or any other modifications made to the sealers. There is no additional justification or testing required to establish equivalency of the equipment.\u003C\u002Fp>\u003Cp>The adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. You are in the process of implementing CAPA-203842 to address GWI-0704-07 REV AE, \u003Cem>Process Confirmation for Sterile Barrier Sealing\u003C\u002Fem>, and FM-7.4-3 REV AC, \u003Cem>Sterile Barrier Sealing Confirmation\u003C\u002Fem>, not aligning with GSOP-00002 REV AD, \u003Cem>Validation Program\u003C\u002Fem>, nor GSOP-7.5-1 REV BA, Process Validation. In addition, your response confirmed that the work instructions and form lacked objective evidence to justify equipment equivalency. You are in the process of completing a Health Hazard Assessment (HHA- FY26-071-A) to evaluate any risks associated with sterile barriers for distributed products.\u003C\u002Fp>\u003Cp>iii. Your firm failed to operate your heat sealers at the validated setpoints used for the Powerseal vessel sealing products. Heat sealer numbers 19-11821 and 23-70915 are only calibrated for time at 5 seconds and 10 seconds, but the nominal setpoint is 3 seconds according to your procedure \u003Cem>POWERSEAL MP: Tray Sealer Setup and Peel Test\u003C\u002Fem> DN0044870 Rev AE. There is no documented justification on why this calibration is acceptable to demonstrate accuracy at the validated setpoint, or potential impact on packaging seal quality and sterile barrier integrity for the Powerseal products.\u003C\u002Fp>\u003Cp>The adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. For example, GSOP-7.18-1 REV AT, \u003Cem>Control of Inspection, Measuring, and Test Equipment\u003C\u002Fem>, does not ensure consistent implementation of calibration across the intended use range. Additionally, the supporting work instruction, GWI-0718-03 Rev AB \u003Cem>Completing a Calibration Request Form\u003C\u002Fem>, lacked sufficient clarity to implement the requirements of GSOP-7.18-1. Your firm plans to revise GWI-0718-03 to improve clarity, include a requirement to notify external calibration vendors of specification changes, and ensure calibration point selection is documented with clear rationale. The calibration request form (FM 7.18-1) will also be updated to provide traceability, reference the revised work instruction, and ensure alignment with validated set points. GSOP-7.18-1 will be updated to explicitly require calibration points to cover validated set points, document rationale for selected calibration points, and mandate re-evaluation of calibration points when validation parameters or process conditions change.\u003C\u002Fp>\u003Cp>b. At the Hinode facility, your firm failed to adequately validate critical process parameters of the \u003Cstrong>(b)(4)\u003C\u002Fstrong> to the heat sealing process. An Operational Qualification (OQ) for the heat sealing process for the MAJ-210 Single Use Biopsy valve was conducted in July 2024, after \u003Cstrong>(b)(4)\u003C\u002Fstrong> to the heat sealing packaging process to address seal wrinkle defects; however, the process parameters and validation are inadequate. The process parameter range shown in the Operational Qualification lists a lower set value of \u003Cstrong>(b)(4)\u003C\u002Fstrong> liters\u002Fminute and a higher set value of \u003Cstrong>(b)(4)\u003C\u002Fstrong> liters\u002Fminute, which is flawed because the \"lower\" limit exceeds the \"higher\" limit. The OQ documentation does not detail how the \u003Cstrong>(b)(4)\u003C\u002Fstrong>.\u003C\u002Fp>\u003Cp>The adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. Your firm completed an investigation and root cause analysis under CAPA-203908, and as a result, updated GSOP-00002 to provide instruction for how to identify process parameters that require control in a validated process. Your firm is also planning to conduct a review of all validated manufacturing processes in place at the facility to confirm that process parameters are adequately controlled.\u003C\u002Fp>\u003Cp>c. At the Aomori facility, your firm failed to validate the cleaning process for metal components used in the production of the HX-610 EZ Clip (hemostasis clip) made according to procedure DC00736661 to remove dirt or other particles. For example, the procedure doesn’t include defining and validating all critical process parameters with acceptable ranges including cleaning solution (type, concentration, temperature), immersion time, drying parameters, and visual inspection criteria.\u003C\u002Fp>\u003Cp>The adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. Your firm initiated a Global Ship Hold (ID.530) and CAPA 203781 as part of your corrective actions.\u003C\u002Fp>\u003Cp>d. At the Shirakawa facility, your firm did not adequately validate the testing process used in the production of UHI-4 Insufflation Unit where the results could not be fully verified by subsequent inspection and testing. For example, the software-driven functional testing process used to evaluate device performance was not adequately validated to ensure that it consistently produced devices meeting specifications in that it did not include appropriate test cases to demonstrate user requirements met acceptance criteria.\u003C\u002Fp>\u003Cp>The adequacy of your firm’s response cannot be determined. Your response states that process validation deficiencies are being addressed through ongoing remediation activities and global CAPA efforts, and that validation activities are planned or underway to ensure processes consistently produce conforming devices. You have not provided objective evidence demonstrating that process validation activities have been completed or that affected processes have been validated, including validation protocols, reports, or data demonstrating that processes consistently produce conforming devices.\u003C\u002Fp>\u003Cp>4. Failure to establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met, as required by 21 CFR 820.75(b). For example,\u003C\u002Fp>\u003Cp>a. At the Brooklyn Park facility, your firm failed to establish adequate process monitoring to ensure validated sealing processes for the heat sealers used for the Powerseal vessel sealing and Miscellaneous Urology products continue to meet specifications throughout production. Per procedure \u003Cem>Peel Strength Test Method for Trays and Pouches\u003C\u002Fem> D5100327-001 Rev AL, the heat sealer for Powerseal products requires peel strength testing to be completed at the beginning and the end of a lot. The process monitoring does not demonstrate that the heat sealing meets specification throughout the manufacturing operations, nor does the process monitoring demonstrate the machine was fully set up and operational when heat sealing process for a lot occurs over multiple days. The DHR for Lot \u003Cstrong>(b)(4)\u003C\u002Fstrong> notes that the sealing took place over two days. However, the process monitoring was conducted according to the procedure and only had a single tray sealing sample for testing at the start of the lot on June 20, 2025, and at shutdown on June 23, 2025. Your firm’s procedure for set-up, “\u003Cem>POWERSEAL MP: Tray Sealer Setup and Peel Test\u003C\u002Fem>” DN0044870 Rev AE states in \u003Cstrong>(b)(4)\u003C\u002Fstrong> for the temperature to stabilize prior to use; however, there is no indication that this was done at the start of the second production day. This step is identified as critical, according to your firm’s Symbol Index in DN0044870. Additionally, the sealing procedure, D5100327-001, is also used for the Miscellaneous Urology line and the Cutting Forceps line and requires the pull strength testing be performed at the beginning and end of every day. Your firm has not assessed whether critical parameters remain in control during all production activities, including after equipment set up on subsequent production days and when processing multiple products with different configurations on the same day. Finally, your procedure \u003Cem>Process Monitoring - Packaging Data Review\u003C\u002Fem> D0300188-001 Rev AK states in section 4, step 2 that a process control analysis should include an evaluation of lower and upper control limits. However, these limits are not currently calculated by your firm, and the upper and lower bound specifications are used instead. There is no documented statistical rationale for this decision.\u003C\u002Fp>\u003Cp>The adequacy of your response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. Your firm opened CAPA-203867 to capture corrective actions such as the retraining of employees on process monitoring requirements to include peel testing at the beginning and end of each lot for the affected product lines. You note that you will revise FM-7.5-10, Control Plan requirements with risk assessments to define and align appropriate sample sizes and frequency monitoring. Ongoing actions as part of CAPA-203867 include defining, establishing, and implementing risk-based requirements in Process Controls, GSOP-7.5-4, for ongoing validated process monitoring. You have not performed an assessment of potentially affected units in the field and any ongoing post market monitoring to assess any risks of commercially distributed product. Your firm plans to review all process monitoring plans subject to D0300188-001 Rev AK, to ensure that such plans include justified control limits as well as specification limits. Your firm has not implemented calculated control limits.\u003C\u002Fp>\u003Cp>5. Failure to ensure that when changes or process deviations occur, the manufacturer shall review and evaluate the process and perform revalidation where appropriate, as required by 21 CFR 820.75(c). For example,\u003C\u002Fp>\u003Cp>a. At the Hinode facility, your firm failed to revalidate the heat sealing process after implementing process changes in response to seal defects in the MAJ-1555. CAPA-202690 identified the cause of the overlap defects as a misalignment of the bag surfaces when the bag enters the sealing operation to create the sterile barrier. To address this issue, your firm added a sensor to control opening and closing of the extraction arm and receiving arm, which impacts bag surface alignment during sealing. Operational qualification or performance qualification was not performed after these changes to validate that the modified process continued to meet specifications and quality attributes.\u003C\u002Fp>\u003Cp>This is a repeat violation from our 2023 Warning Letter issued to the Hinode facility.\u003C\u002Fp>\u003Cp>The adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. Following an investigation and root cause analysis under CAPA-203919, your firm revised GSOP-00002 to provide additional instruction on how to assess whether a manufacturing change triggers revalidation of the manufacturing process, and your firm established the guidance document GREF-00197 to provide revalidation guidelines. The verification of effectiveness of these actions is not yet complete, and it is unclear whether concerns with process validation have been adequately addressed for other products subject to sealing at your facility. Your response stated that all seals are subject to visual inspection and, therefore, any nonconforming seals would be detected prior to release; however, visual inspection is not a substitute for adequate process validation.\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cu>Corrective and Preventive Action Violations – Brooklyn Park, Shirakawa, Hinode, Hachioji, Hamburg, and Aomori facilities:\u003C\u002Fu>\u003C\u002Fem>\u003C\u002Fp>\u003Cp>6. Failure to identify the action(s) needed to correct and prevent the recurrence of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(3). Specifically,\u003C\u002Fp>\u003Cp>a. At the Brooklyn Park facility,\u003C\u002Fp>\u003Cp>i. Your firm failed to identify corrective actions that address the full scope of multiple Line Clearance Control nonconformances on the Miscellaneous Urology Production Line. CAPA-201354 was opened on August 31, 2023, and included automated verification steps and automated inspections on the lines. However, the CAPA only included implementing the automated verifications for the Soltive laser fibers and did not address corrections for any of the other products made on the Miscellaneous Urology production line, including nonconformances associated with missing syringes in the Irri-Flow line or incorrectly labeled RB Electrodes, as listed in the CAPA Initiation Information.\u003C\u002Fp>\u003Cp>The adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. Your firm opened and is developing an action plan for CAPA-203705, which revealed that the Miscellaneous Urology product line lacks sufficient process controls and robust automation and further noted that this technical gap creates a potential for the recurrence of nonconformances. While a quality plan was developed per GSOP-5.5-1 Rev AB \u003Cem>Quality Plans\u003C\u002Fem> to address the remaining implementation requirements for this line, the execution of these corrective actions occurred outside of the formal CAPA framework and did not include verification of effectiveness.\u003C\u002Fp>\u003Cp>ii. Your firm failed to identify corrective actions to address ongoing Supplier Quality Performance rate failures for Vizishot endoscopic aspiration needle slider components. CAPA-202086 was opened on August 15, 2024, to address the Supplier Quality Performance rate (SQ3) not meeting the KPI objective for more than three months in a row. The investigation identified root causes related to supplier capability gaps, including inadequate manufacturing processes, insufficient purchase order review, and delayed drawing revisions. A separate NCR-00028865 due to a SQ2 KPI signal (Part Failure Rate) was escalated to CAPA-202086 on May 20, 2025. CAPA-202086 was closed on October 16, 2025, with no corrective or preventive actions taken, and the SQ3 KPI was eliminated without addressing the underlying quality problems or providing a rationale for no action taken.\u003C\u002Fp>\u003Cp>The adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. CAPA-203869 confirmed that the early closure of CAPA-202086 occurred because GSOP-00023, Rev AF \u003Cem>Global Corrective Action and Preventive Action Management\u003C\u002Fem> and GWI-00014, Rev AB \u003Cem>CAPA Management Work Instruction\u003C\u002Fem> – Agile did not clearly define requirements for early closure rationale or verification of linked records. An action plan is being developed but has not yet been implemented for CAPA-203869.\u003C\u002Fp>\u003Cp>iii. Your firm identified a root cause for the blue ring on the Powerseal vessel sealing device detaching from the rotation knob during use (operator error during assembly) but failed to implement corrective actions consistent with that root cause. CAPA-200547 was opened on July 22, 2022, for the detachment, which resulted in a recall (RES 90788). The CAPA found the root cause was an operator error during assembly and not the out of specification supplier component originally documented in the HHA FY23-OSTA-07. However, the scope of corrections for the recall were based on supplier component lots and the scope was not expanded to include all devices assembled during the period when the operator error occurred, allowing potentially defective devices to remain in distribution.\u003C\u002Fp>\u003Cp>The adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. Your firm opened CAPA-203868 and noted that the Health Hazard Assessment (HHA) and Field Corrective Action (FCA) for CAPA-200547 were not reassessed after the identified root cause changed, as procedure GSOP-00023 Rev AF \u003Cem>Global Corrective Action and Preventive Action Management\u003C\u002Fem> did not define requirements for re-evaluation when new investigation findings modify the identified failure mode. Your firm indicated that since the process is shared among sites, the process related aspects of this observation are being addressed separately under Global CAPA-203799. An action plan is being developed but has not yet been implemented for CAPA-203868.\u003C\u002Fp>\u003Cp>b. At the Shirakawa facility, your firm failed to identify corrective actions needed to correct and prevent the recurrence of known quality problems associated with the UHI-4 insufflation system. CAPA-200872 identified pressure sensor failures as the root cause of front panel display issues; however, you relied on prior corrective actions (SCAR-Shirakawa-152-06) and concluded that the risk remained acceptable despite 325 complaints. Your firm failed to implement adequate corrective actions to address supplier control failures, complaint trending deficiencies, and design and risk management process gaps that allowed these repeated failures. As a result, your supplier control processes failed to prevent defective components from entering production and your quality system failed to detect and escalate recurring defects.\u003C\u002Fp>\u003Cp>The adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. Your response noted planned corrective actions, including reliance on global CAPA procedures (GSOP00023) and proposed improvements to complaint trending, supplier controls, and risk management processes. You indicated that CAPA deficiencies continue to be addressed through ongoing local and global CAPAs and that you have initiated additional CAPAs (e.g., CAPA-203879, CAPA-203856, CAPA-203877).\u003C\u002Fp>\u003Cp>c. At the Hinode facility, your firm’s CAPA procedures failed to ensure that corrective actions addressed the root causes and prevented recurrence. Between October 2022 and September 2025, three CAPAs (CAPA-200736, CAPA-201399, CAPA-203398) were opened for wrinkle defects in sterile barrier seals across five products (MAJ-2315, MAJ-1555, MAJ-209, MAJ-210, MAJ-287). Each CAPA identified inadequate process validation as a contributing factor, yet none implemented corrective actions to address the underlying validation methodology deficiency that allowed critical process parameters to be missed. For example, CAPA-203398 identified the root cause as \"Method Inadequate validation\" but did not implement corrective actions to address the validation failure. CAPA-201399 identified wrinkles across multiple products but concluded that inspection would remove nonconforming product, without implementing corrective actions to the validated processes producing defects. CAPA-200736 \u003Cstrong>(b)(4)\u003C\u002Fstrong> to address wrinkles but did not investigate why \u003Cstrong>(b)(4)\u003C\u002Fstrong> identified in initial validations. Wrinkle defects may create channels for microbial contamination.\u003C\u002Fp>\u003Cp>The adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. Your firm characterized the pattern of recurring CAPAs for seal defects as representative of continuous improvement, citing decreases in defect rates, and your firm characterized the sealing processes as “under control”. However, ongoing nonconformances were initiated for wrinkles even after CAPAs were initiated. Your responses do not appear to address why your CAPA process allowed the same problem to require three separate CAPAs over three years without implementing corrections to the validation methodology.\u003C\u002Fp>\u003Cp>d. At the Hachioji facility, your firm failed to identify corrective actions for CAPA 201212, initiated June 20, 2023, in response to an FDA Additional Information request related to a patient death following use of the Evis Exera III Bronchovideoscope. Your CAPA documented that your firm failed to conduct design verification for use conditions and accessory compatibility claims in your IFU; however, no corrective actions were taken to address these design control deficiencies and the suspension of shipping was lifted on July 28, 2023. Your investigation revealed that your firm received 210 similar complaints and your investigation was not completed until November 14, 2025, over two years after CAPA initiation and your decision to continue shipping the devices.\u003C\u002Fp>\u003Cp>The adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness.\u003C\u002Fp>\u003Cp>7. Failure to verify or validate the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4). For example,\u003C\u002Fp>\u003Cp>a. At the Brooklyn Park facility,\u003C\u002Fp>\u003Cp>i. Your firm implemented actions to address root causes of a Vizishot II component mix-up without classifying them as corrective actions and verifying their effectiveness. CAPA-203041 was opened on June 30, 2025, for the use of the 21G slider components instead of the 22G on the Vizishot II NA-U401SX-4022 line. The Early Closure memo states that “operators were retrained on the line clearance procedure GWI-0705-16 and \u003Cstrong>(b)(4)\u003C\u002Fstrong>” and “the \u003Cstrong>(b)(4)\u003C\u002Fstrong> was modified to restrict access to the sides…”. Neither of these actions were considered a corrective action, nor was a verification of effectiveness conducted to ensure these actions prevented recurrence of the component mix-up.\u003C\u002Fp>\u003Cp>The adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. CAPA-203041 was prematurely closed because actions taken under the NCR were misclassified as corrections, even though they addressed root-cause-level factors that required corrective actions and verification of effectiveness (VOE). GSOP-00023 Rev AF \u003Cem>Global Corrective Action and Preventive Action Management\u003C\u002Fem> did not explicitly distinguish correction from corrective action within the CAPA workflow, which contributed to the omission of VOE. Your firm also indicated an action plan is being developed but has not yet been implemented for CAPA-203705.\u003C\u002Fp>\u003Cp>ii. Your procedures, \u003Cem>Quality Planning\u003C\u002Fem> QSP-5.5 Rev AL and \u003Cem>Quality Plans\u003C\u002Fem> GSOP-5.5-1 Rev AB, have not adequately defined when quality plans contain corrective or preventive actions and should contain a verification that changes are effective and do not adversely affect devices. These procedures do not adequately define the difference between a quality plan and a corrective or preventive action. Additionally, during the inspection your firm had 54 quality plans open, including multiple plans intended to address backlogs in the complaint system and late MDRs. These quality plans directly address deficiencies in your quality system and are also being referenced within and in conjunction with CAPAs addressing the same issues.\u003C\u002Fp>\u003Cp>The adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. CAPA-203836 determined that the current procedures lack defined criteria for determining when a Quality Plan is not appropriate and a CAPA is required and does not require oversight to ensure appropriate use and completion tracking of Quality Plans. The \u003Cem>Quality Management Review Presentation Template\u003C\u002Fem> GTMP-00077 was revised to require that quality plans be reviewed as part of the Quality Management Review process. The scope of affected quality plans that lacked VOE was not provided. An action plan is being developed but has not yet been implemented for CAPA-203836.\u003C\u002Fp>\u003Cp>b. At the Shirakawa facility, your firm failed to verify that corrective actions implemented for overpressure events for the UHI-4 Insufflator were effective in preventing recurrence. For example, CAPA-200872 (opened February 2023) relied on prior corrective actions related to pressure sensor failures and concluded that these actions were effective without demonstrating that they prevented recurrence of similar defects or adequately mitigated risk in distributed devices. CAPA-201353 (opened August 2023) was subsequently opened to address overpressure events associated with the UHI-4 insufflation system only after significant adverse events occurred, including cardiac arrest and possible gas embolism, and resulted in a Class I recall (RES 92932). Your CAPA activities did not demonstrate that corrective actions were verified or validated to ensure effectiveness in preventing recurrence of overpressure-related failures.\u003C\u002Fp>\u003Cp>The adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. Several CAPAs remain open, and you have not demonstrated that corrective actions have been verified or validated to ensure effectiveness or to prevent recurrence of similar defects, including overpressure-related failures.\u003C\u002Fp>\u003Cp>8. Failure to analyze processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems, as required by 21 CFR 820.100(a)(1). For example,\u003C\u002Fp>\u003Cp>a. At the Brooklyn Park facility, your firm is using statistical methods for complaint trending without a documented rationale for the appropriateness of those methods. \u003Cem>Complaint Trending Attributes, Statistical Method, and Trending Rules\u003C\u002Fem> GREF-00157 Rev AA defines your complaint quality data analysis method of using median values and recalculating control limits each month. During the inspection your employees noted the calculations used were originally chosen in 2020, due to COVID-related data irregularities. However, you acknowledged that your firm does not still see these data irregularities and confirmed your firm has not documented a re-assessment or other justification for why this analysis method is still appropriate. The use of median values and monthly recalculation of control limits (that may not be appropriate for post-COVID data) may mask trends or delay detection of increasing complaint rates, potentially allowing serious device problems to persist undetected.\u003C\u002Fp>\u003Cp>The adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. CAPA-203873 determined that Olympus lacks a global procedure or guidance for statistical techniques, resulting in the absence of defined expectations for the consistent implementation of statistical methods. An action plan is being developed but has not yet been implemented for CAPA-203873.\u003C\u002Fp>\u003Cp>b. At the Shirakawa facility, your firm did not adequately analyze quality data, including complaints and adverse event information, to identify causes of quality problems. For example, you received a high volume of complaints related to pressure sensor defects and front panel failures associated with the UHI-4 insufflation system (including 325 complaints between November 2020 and October 2022), yet you did not appropriately trend or escalate these data to identify a cause or initiate CAPA in a timely manner. Additionally, you were aware of pressure sensor defects as early as 2018–2021 but did not reassess risk or investigate the increased occurrence of these defects in distributed devices. A CAPA was not initiated until FDA inquiry, indicating that your quality system did not effectively analyze available data sources, including complaints, supplier information, and risk management records.\u003C\u002Fp>\u003Cp>We reviewed your firm’s response and determined that it is not adequate. Your response states that CAPA deficiencies are being addressed through a combination of local and global CAPAs, including local CAPA-203879, CAPA-203856, CAPA-203850, and global CAPA-203789, CAPA-203525, and CAPA-204150. You indicate that updates to procedures, including GSOP-00023 (CAPA), GSOP-00033 (complaint trending), GSOP-00069 (supplier quality agreement), and GSOP-00079 (supplier corrective action), have been implemented or are in progress. You also state that retrospective reviews of complaint data and supplier corrective action requests have been conducted. Several CAPAs remain open and root cause investigations and corrective actions are ongoing. Additionally, you indicate that certain local CAPAs will be closed early and that corrective actions will be addressed under global CAPAs, which limits the ability to assess whether site-specific deficiencies have been adequately addressed. Your response further confirms that complaint trend signals were not adequately identified and that supplier-related defects were not appropriately evaluated for field impact at the time they were identified. You have not provided sufficient objective evidence demonstrating implementation or effectiveness of corrective actions, including completion of investigations, verification of corrective actions, or sustained improvements to your CAPA system.\u003C\u002Fp>\u003Cp>c. At the Hamburg facility, your firm’s complaint trending failed to include all complaints as required by your procedure. \u003Cem>Trending Attributes, Statistical Method, and Trending Rules\u003C\u002Fem> GREF-00157 Rev AA, section 4.4.2 states “trending will be based on the value of monthly data (i.e. actual number of open complaints per month).” However, trend signal information (TS-1224-WA50042A) for your video telescope (model WA50042A) only includes the trending of MDR reportable complaints and does not include non-reportable complaints.\u003C\u002Fp>\u003Cp>We reviewed your firm’s response and determined that it is not adequate. Your response did not include an assessment of how the lack of trending of non-reportable complaints may impact already distributed product. For example, if the complaints reveal quality problems that may require correction or removal to address.\u003C\u002Fp>\u003Cp>d. At the Aomori facility,\u003C\u002Fp>\u003Cp>i. Your firm failed to adequately analyze quality data to identify causes of nonconforming product. CAPA-201434, which was initiated to address reports of deformed wires for the Single Use 3-Lumen Sphincterotome, incorrectly identified the root cause as “shortcomings in work procedures” during outsourcing, failing to recognize inadequate design transfer to production specification as the actual cause. Per the CAPA scope, the corrective actions only applied to products distributed to the Japanese market and were not implemented for devices distributed to the U.S. market. It was noted during the inspection that the CAPA task (Task 10012651) assigned to correct the manufacturing process for products destined for the U.S. was cancelled because the products are subject to FDA 510(k) and it would have taken longer to implement the changes which would “prolong the period until the CAPA closes.” Your firm received over 1000 complaints for this device failure, including 24 MDR reportable events.\u003C\u002Fp>\u003Cp>ii. Your firm failed to conduct a timely and adequate analysis of complaint data related to potential causes of nonconforming product for the Thunderbeat 5 mm Front-actuated Grip Type S. Your firm received over 1900 complaints between September 2021 and September 2024, including 1583 that were MDR reportable. CAPA-201438 was initiated on October 18, 2023, but no action was taken as the Health Hazard Evaluation was canceled on January 31, 2024, because it was deemed not necessary based on complaint incident rates and without considering the potential harm to patients. A recall (RES 95950) was initiated on November 25, 2024, over a year later.\u003C\u002Fp>\u003Cp>The adequacy of your firm’s response for (i) and (ii) above cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness.\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cu>Acceptance Activities Violations – Brooklyn Park and Shirakawa facilities:\u003C\u002Fu>\u003C\u002Fem>\u003C\u002Fp>\u003Cp>9. Failure to establish and maintain procedures for acceptance of incoming product, as required by 21 CFR 820.80(b). For example,\u003C\u002Fp>\u003Cp>a. At the Brooklyn Park facility, your firm failed to conduct statistical calculations required to demonstrate lot acceptability in accordance with your procedure. \u003Cem>Receiving Acceptance\u003C\u002Fem> GSOP-7.11-1 Rev AT uses a variable sampling plan for receiving inspection of part number 0000315-TAB, according to \u003Cem>Inspection Procedure for 0000315-TAB JAW ASSEMBLY, MACHINED, INNER, POWERSEAL CURVED JAW B\u003C\u002Fem> DN0040655 Rev AE. However, your receiving inspection for each length of this part (PN 0000315-001, 0000315-002 and 0000315-003) does not include calculation of your standard deviation, kLSL, and kUSL as required by GSOP-7.11-1. Additionally, your acceptance procedure for Powerseal Curved Jaw B only includes a specification for sample calculation for dimension 9 but does not document a calculation of the maximum standard deviation (MSD) for any other dimension as required. Finally, your Supplier D also uses the sampling plan, but does not provide you with their standard deviation, kLSL and kUSL calculations. The calculations for standard deviation, lower controls limits and upper control limits are part of the variable sampling plan that demonstrate the acceptability of the lot.\u003C\u002Fp>\u003Cp>Your inspection procedure also allows for CMM measurements to be re-tested by another inspector if they do not pass initially. This was done for 8 of the 10 samples in the \u003Cem>FAI Inspection Request\u003C\u002Fem> for part number 0000315-002, dated March 20, 2025. The only rationale recorded was \"Believed fixture incorrect.\" Our inspection also found that retesting had occurred on all of the most recent receiving records for all sizes of the 000315-TAB. Part Number 0000315-001 was inspected on October 23, 2025, and the record includes failing CMM results for 5 of the 10 parts, as well as the retested data, but the parts were accepted into inventory. When our investigator communicated this to your employee, it was noted that this lot was accepted by mistake and NCR-00048701 was opened to contain the nonconforming material.\u003C\u002Fp>\u003Cp>We reviewed your firm’s response and determined that it is not adequate. CAPA-203866 was opened to capture corrective actions and noted that GSOP 7.11-1 Rev. AU, \u003Cem>Receiving Acceptance\u003C\u002Fem>, and the inspection procedures did not define the statistical requirements, resulting in incomplete evaluation of incoming product and acceptance of parts without proper statistical justification. Your response noted that you have updated the inspection procedures for all parts subject to ANSI\u002FASQ Z1.9 to require inclusion of sample size rationale for critical dimensions and to ensure that data is provided by their suppliers. Your firm plans to conduct a retrospective review of inspection records from the past 2 years for failed dimensions without a record of appropriate retest or passing results. Based on the results of the review you will take appropriate action; however, it is not clear what those actions would include, nor if the actions will include a risk assessment for product that has been distributed.\u003C\u002Fp>\u003Cp>b. At the Shirakawa facility, your firm failed to identify defective components used in the UHI-4 insufflation system during acceptance activities. For example, defective pressure sensor components were not identified through incoming inspection or acceptance testing prior to use in manufacturing. As a result, nonconforming components were incorporated into finished devices, contributing to reports of device malfunctions and adverse events received by your firm.\u003C\u002Fp>\u003Cp>The adequacy of your firm’s response cannot be determined. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. Your response states that improvements to incoming acceptance activities will be implemented as part of broader corrective actions, including updates to ensure that purchased materials meet specifications. However, you have not provided sufficient detail demonstrating that revised acceptance activities have been implemented or are effective in detecting nonconforming components.\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cu>Purchasing Controls Violations – Brooklyn Park, Shirakawa and Hamburg facilities:\u003C\u002Fu>\u003C\u002Fem>\u003C\u002Fp>\u003Cp>10. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product, and services conform to specified requirements, as required by 21 CFR 820.50. For example,\u003C\u002Fp>\u003Cp>a. At the Brooklyn Park facility,\u003C\u002Fp>\u003Cp>i. Your firm’s supplier controls procedure (GQS-00013) does not ensure that supplied product that cannot be fully verified by subsequent inspection and test is validated with a high degree of assurance and conforms to specified requirements. On December 4, 2023, your firm issued SCR-0000649 for an increased rate of complaints for broken welds in the ESG PK Cutting Forceps (model PK-CF0533), occurring in the supplied bottom and top jaw assemblies (part numbers P5700259-001 and P5700260-001, respectively). Supplier A determined the cause of the weld breaking was a sub-supplier, Supplier B. In SCR-0000649, Supplier A documented that Supplier B stated the welding process \"could not be controlled or validated.\" Your firm established increased inspection rather than requiring validation or changing suppliers. This complaint trend resulted in a recall (RES 93842) in December 2023. This unvalidated welding process has resulted in weld failures during patient use, creating risk of foreign bodies in patients assessed at Critical (S4) severity and High (S5) probability. Similar welds are also performed by Supplier B for your Halo and Cutting Forceps. Approximately 4,600 units with similar unvalidated welds have been distributed. During the inspection, your firm initiated an NCR and a Global Ship Hold.\u003C\u002Fp>\u003Cp>We reviewed your firm’s response and determined that it is not adequate. CAPA-203871 was opened to address the failure to ensure welding performed by the supplier was validated. The CAPA root cause investigation identified that the QAA template used to finalize the Supplier Agreement back in 2014 did not incorporate process validation requirements for suppliers and their Sub-Tier suppliers. Moreover, the Global QAA templates GTMP-00021 Rev AB \u003Cem>QAA Template for Component Suppliers\u003C\u002Fem> and GTMP-00022 Rev AB \u003Cem>QAA\u003C\u002Fem> \u003Cem>Template for Finished Device Suppliers\u003C\u002Fem> lack specificity on sub-tier control for process validation. All impacted product remains on Global Ship Hold (ID 476), and you have halted the manufacture of affected product. The FCA board reviewed and decided to conduct a removal of the impacted products. Your response stated you would submit a Correction and Removal report in compliance with 21 CFR Part 806 requirements. Although an expansion of the recall is being performed, it has been over 2 years between awareness (December 4, 2023) and recall decision (February 3, 2026). Your firm has not explained the delay or assessed patient harm during this period.\u003C\u002Fp>\u003Cp>ii. Your firm accepted failing process capability data after components were remeasured without justification. SCR-0000166 was issued to Supplier C for out of specification components. The investigation led to two design changes to the mating parts used in the Powerseal vessel sealing device: the blue ring (part PN0013810) and the overmolded rotation knob (part PN0013804) and resulted in a class II recall (RES 90788). You accepted first article inspection that included Supplier C “Validation Documents Submission” where parts were remeasured with passing results, “Ppk’s for Cav 2 on PQ1 was right at 1.39 and PQ2 was 1.36 failing the Ppk requirement per protocol of 1.39. 2 parts were remeasured and Ppk came into requirement.” There is no justification for why these remeasurements were considered appropriate.\u003C\u002Fp>\u003Cp>We reviewed your firm’s response and determined that it is not adequate. CAPA-203872 is ongoing, and the root cause investigation identified that the supplier procedure permitted data remeasurement without documented justification and did not define requirements for documenting the rationale or controls associated with remeasurement activities. In addition, GSOP-00086 Rev AA \u003Cem>Global External Product Qualification\u003C\u002Fem> lacked requirements for justification of remeasurement. Your firm’s response notes that you have planned the process to requalify Supplier C against new global procedure requirements by March 27, 2026, including a new Quality Agreement. The impact on released product has not been evaluated since this will involve the remeasurement at incoming testing after you have updated GSOP-00086 that governs the conditions and permissibility for remeasurement. Your firm has not provided interim results or identified how many additional components may be affected. Your response should also include a retrospective review of similar supplier processes that pose a potential for patient safety risk.\u003C\u002Fp>\u003Cp>iii. Section 3.5 of \u003Cem>First Article Inspection\u003C\u002Fem> GSOP-7.11-2 Rev AG, allows suppliers on risk improvement plans with documented quality concerns to conduct first article inspections without additional verification by your firm. For example, Supplier D has been on a risk improvement plan since January 21, 2025, but a \"Supplier conducted FAI\" for part number 0000315-002, delivered on or before March 5, 2025, and used in the Powerseal vessel sealing device. The process is currently controlled by the two procedures \u003Cem>Global Supplier Risk Improvement \u003C\u002Fem>GSOP-00045 Rev AB and \u003Cem>Global Supplier Risk Improvement with Action Plan\u003C\u002Fem> GWI-00002 Rev AB. Despite the supplier providing out-of-specification components and being on a supplier risk improvement plan, your firm failed to consider the appropriateness of the supplier performing first article inspection measurements following a design change or when implementing a new component.\u003C\u002Fp>\u003Cp>We reviewed your firm’s response and determined that it is not adequate. CAPA-203866 identified that GSOP-00045 Rev AB \u003Cem>Global Supplier Risk Improvement\u003C\u002Fem> does not require evaluation of internal inspection plans when supplier risk improvement plans are issued or revised in response to changes in part failure rate. Additionally, the procedure lacks defined linkage between supplier risk improvement plans and corresponding receiving inspection requirements. It is not clear from your response whether there is nonconforming product in the field associated with suppliers who are on a heightened inspection status or risk improvement plan and who conducted their own supplier first article inspections.\u003C\u002Fp>\u003Cp>iv. Supplier A has not adequately validated their \u003Cem>Performance Qualification Report\u003C\u002Fem> PQR-10774 Rev A for part number P5700138-001, used to support the weld tensile strength in your legacy Cutting Forceps. According to your firm’s Engineer, the worst-case weld is considered the shortest weld of the group, as the welds all have to meet a minimum weld pull strength of 30 lbs. However, part P5700138-001 has a weld length specification of 0.10 ± 0.02 inches, while parts P5700211-002 and P5700210-002 have a shorter weld length specification of 0.081 ± 0.02 inches.\u003C\u002Fp>\u003Cp>We reviewed your firm’s response and determined that it is not adequate. CAPA-203871 was opened and a Health Hazard Assessment (HHA) FY26-062 was conducted to evaluate potential field action. On February 3, 2026, the FCA board reviewed and decided to conduct a removal of the impacted products in the Cutting Forceps product line (RES 98454). Olympus completed the review of validations for Supplier A to determine conformance with Global GSOP-00002 Rev AD \u003Cem>Validation Program\u003C\u002Fem> and GWI-00112 Rev AA \u003Cem>Global Standards for External Product Qualification\u003C\u002Fem> for worst-case trials with documented rationale. The review determined that three (3) components manufactured by Supplier A require additional process validation. The review, however, was limited to products with an active production schedule. Products that have reached end-of-life and are in the process to be discontinued were excluded from the scope (jaw assemblies, ESG Cutting Forceps, Halo, Everest 5mm Cutting Forceps, and PKS Cutting Forceps). It is not clear from your response whether there is product within expiry date that is still in commercial distribution. Your firm will complete a review of applicable supplier-manufactured components documentation, through collaboration with suppliers to identify potential validation gaps.\u003C\u002Fp>\u003Cp>b. At the Shirakawa facility, your firm did not adequately control suppliers to ensure that components used in the UHI-4 insufflation system met specified requirements. For example, pressure sensor defects associated with supplier-provided components were identified; however, your supplier control processes did not prevent nonconforming components from being incorporated into finished devices. Your CAPA investigations did not adequately evaluate why supplier controls were ineffective or ensure that appropriate corrective actions were implemented to prevent recurrence of similar supplier-related defects. Root cause analysis identified gaps in supplier change control procedures and audit processes, including lack of mechanisms to verify supplier changes against specifications.\u003C\u002Fp>\u003Cp>The adequacy of your firm’s response cannot be determined. Your response states that supplier control deficiencies are being addressed through local and global CAPAs, including CAPA-203856 and CAPA-203789, and that supplier oversight processes will be enhanced through updated supplier quality agreements and risk-based supplier requalification activities. You also indicate that procedures, including GSOP-00079, have been updated to require assessment of field impact for supplier-related defects. However, investigations into supplier-related root causes remain ongoing, and corrective actions have not been fully implemented. Additionally, you indicate that certain local CAPAs will be closed early and that corrective actions will be addressed under global CAPAs, which limits the ability to assess whether site-specific supplier control deficiencies have been adequately addressed. You have not provided objective evidence demonstrating that revised supplier controls are effective in preventing recurrence of nonconforming components.\u003C\u002Fp>\u003Cp>c. At the Hamburg facility, your firm failed to ensure that purchased services conform to specified requirements. Your firm hired HCL Technologies as part of “\u003Cstrong>(b)(4)\u003C\u002Fstrong>” to reduce the backlog of complaint investigation and closures; however, your firm did not evaluate HCL Technologies on the basis of their ability to provide contract services to meet specified quality requirements, including their ability to provide qualified staff to perform quality assurance responsibilities. Your firm’s contract services included approximately \u003Cstrong>(b)(4)\u003C\u002Fstrong> temporary personnel to investigate and close complaint files. Your firm was unable to demonstrate that the contract personnel received product specific training.\u003C\u002Fp>\u003Cp>We reviewed your firm’s response and determined that it is not adequate. Your firm initiated CAPA-204033 and CAPA-204034. Your firm indicated that your root cause investigation determined that there was no central governance defining shared services requirements within the Quality Management System (QMS) and that as a result, roles and responsibilities between Legal Manufacturers, Global QMS functions, and shared service owners were not consistently defined or understood, leading to fragmented accountability for end-to-end oversight. Your firm is developing a corrective action plan; however, you have not provided corrective actions demonstrating how you will ensure contract personnel are qualified and trained in the services they will perform.\u003C\u002Fp>\u003Cp>\u003Cstrong>\u003Cu>Records Violations – Brooklyn Park and Shirakawa facilities:\u003C\u002Fu>\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>11. Failure to review, evaluate and investigate any complaint involving the possible failure of a device, labeling or packaging to meet any of its specifications, as required by 21 CFR 820.198(c). For example,\u003C\u002Fp>\u003Cp>a. At the Brooklyn Park facility, your firm's procedure, \u003Cem>Complaint Investigation Tiers and Investigation Activities\u003C\u002Fem> GWI-0809-10 Rev BB, does not require investigations to be completed on complaints in investigation Tier 3. For example, complaints C22097460, C22184070, C22248777, C22249599, C22259835, C22279317, C22332770, and C22387391 all state in the investigation summary that the complaints are “non-PAE, Tier 3 codes. No investigation is required,” in the “Evaluation Result” section (PAE stands for potential adverse event). There is no documentation of a complaint investigation or reference to where an investigation for this failure has previously been investigated or other similar rationale for why this investigation is not required. Lack of investigation only allows trending on this subset of complaints based on date of receipt and device model. After transitioning to your current Trackwise system in November 2024, you indicate you no longer use a tier system; however, your trending is based on 24 months of historical data which is still limited by the lack of investigation results on potential device performance issues.\u003C\u002Fp>\u003Cp>We reviewed your firm’s response and determined that it is not adequate. Your response does not address the failure to investigate complaints.\u003C\u002Fp>\u003Cp>b. At the Shirakawa facility, your firm failed to adequately investigate complaints involving serious adverse events to determine whether device malfunction contributed to the reported outcomes. For example, complaints associated with UHI-4 insufflation systems, including reports of overpressure events and serious adverse outcomes such as cardiac arrest and possible gas embolism, were not fully evaluated to determine whether device malfunction contributed to the reported events. Your complaint investigations did not consistently incorporate available device performance data to determine whether the device met specifications during use. For example, complaint CN-249953 reported a death due to gas embolism during use and included the device event log retrieved by the Field Service Engineer; however, this log was not reviewed as part of the investigation.\u003C\u002Fp>\u003Cp>We reviewed your firm’s response and determined that it is not adequate. You state that complaint handling and trending processes have been improved through implementation of GSOP-00033 and that retrospective reviews of complaint data have been conducted to assess whether complaint signals were appropriately escalated. You also indicate that CAPA-203879 was initiated to address missed complaint trend signals. However, CAPA-203879 and related investigations remain ongoing, and you have not provided sufficient objective evidence demonstrating that complaint investigations are comprehensive or that systemic issues are consistently identified and escalated.\u003C\u002Fp>\u003Cp>\u003Cstrong>\u003Cu>Medical Device Reporting (MDR) Violations\u003C\u002Fu>\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Our inspection at your Hamburg facility also revealed that your firm’s resection sets are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. Significant violations include, but are not limited to, the following:\u003C\u002Fp>\u003Cp>12. Failure to report the information required by 21 CFR 803.52 in accordance with the requirements of 21 CFR 803.12(a), no later than 30 calendar days after the day that the firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets has malfunctioned and this device or a similar device that the firm markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2).\u003C\u002Fp>\u003Cp>For example, the information included in Complaints CN-182867 and CN-184790 reasonably suggests that your firm’s resection set malfunctioned (e.g., broken ceramic insulation) while in use. A serious injury MDR 2951238-2019-00404, submitted by your firm on February 1, 2019, documents a serious injury resulting from the same malfunction involving the same device. That malfunction would be likely to cause or contribute to a death or serious injury if it were to recur, as evidenced by the serious injury MDR 2951238-2019-00404. Accordingly, the referenced adverse events represent MDR-reportable malfunctions as defined under 21 CFR 803.3. Your firm became aware of complaint CN-182867 on February 13, 2025, and submitted the corresponding MDR 9610773-2025-06509 on October 20, 2025; and became aware of CN-184790 on February 12, 2025, and submitted the corresponding MDR 9610773-2025-04016 on June 16, 2025. These two MDRs were submitted beyond the required 30-calendar-day reporting timeframe.\u003C\u002Fp>\u003Cp>The adequacy of your firm’s response cannot be determined at this time. The response states that your firm initiated CAPA-204035 to address late reporting, including revising procedures to correctly document event dates and the dates your firm became aware of the events. However, supporting evidence demonstrating completion of these corrective actions was not provided because the corrective actions are still ongoing.\u003C\u002Fp>\u003Cp>Failure to address any violations of the FD&C Act may result in the FDA refusing admission of the devices manufactured by your firm into the United States under section 801(a) of the FD&C Act, 21 U.S.C. § 381(a). Devices under this authority that appear to be adulterated may be detained or refused admission.\u003C\u002Fp>\u003Cp>Your firm should provide a written response to this Warning Letter as described below and address the violations described in this letter. We will notify you regarding the adequacy of your firm’s responses and the need to re-inspect your firm’s facilities to verify that the appropriate corrections and\u002For corrective actions have been made.\u003C\u002Fp>\u003Cp>Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed.\u003C\u002Fp>\u003Cp>On February 2, 2024, the FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world. The revised part 820, referred to as the Quality Management System Regulation (QMSR), became effective on February 2, 2026. Your most recent inspections conducted between October 2025 and December 2025 were conducted pursuant to the QS Regulation, which was in effect at the time of the inspections. However, any corrective actions you propose or implement must be pursuant to the QMSR requirements in effect as of February 2, 2026. For more information on the QMSR please refer to our frequently asked questions webpage: https:\u002F\u002Fwww.fda.gov\u002Fmedical-devices\u002Fquality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp\u002Fquality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked.\u003C\u002Fp>\u003Cp>In addition, we also note the following comments:\u003C\u002Fp>\u003Cp>1. In response to three prior warning letters issued to your firm in 2022 and 2023 (including the Hachioji and Hinode facilities), your firm implemented new global procedures, including complaint handling, MDR, and CAPA procedures. Review of these procedures found the roles and responsibilities of manufacturing sites versus your global remote corporate entity have not been clearly defined, including, for example, how your firm will assess that site specific quality issues have been resolved, and how your global CAPA process will provide oversight and ensure correction and prevention of repetitive quality issues within and across your global facilities that follow these procedures.\u003C\u002Fp>\u003Cp>2. Regarding the inspection of Olympus Corporation of the Americas, located at 3500 Corporate Pkwy, Center Valley, PA 18034, FEI 2429304, from November 18, 2025, to December 16, 2025: Multiple complaint files reviewed during the inspection were found to contain insufficient documentation of complaint intake, evaluation, and investigation conclusions. Complete complaint files provide your firm with critical information to detect and trend medical device failures and to make reportability decisions.\u003C\u002Fp>\u003Cp>Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and\u002For corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and\u002For corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and\u002For corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.\u003C\u002Fp>\u003Cp>Your firm’s response should be sent via email to \u003Cstrong>Kristina Donohue\u003C\u002Fstrong> at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “\u003Cstrong>CMS #729208\u003C\u002Fstrong>” when replying. If you have any questions about the contents of this letter, please contact: \u003Cstrong>Beckilyn Dorsey\u003C\u002Fstrong> at \u003Cstrong>Rebecca.dorsey@fda.hhs.gov.\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.\u003C\u002Fp>\u003Cp>Sincerely,\u003Cbr>\u002FS\u002F \u003Cbr>Michael J. Hoffmann  \u003Cbr>Director  \u003Cbr>Office of Health Technologies 3 - Gastrorenal, ObGyn,\u003Cbr>General Hospital, and Urology Devices\u003Cbr>Office of Product Evaluation and Quality  \u003Cbr>Center for Devices and Radiological Health\u003C\u002Fp>\u003Cp>CC:\u003Cbr>Todd Brill, US Agent, Gyrus ACMI, Inc., \u003Cstrong>(b)(6)\u003C\u002Fstrong>@Olympus.com\u003Cbr>Daniel S. Sampson, Senior Director of Operations, \u003Cstrong>(b)(6)\u003C\u002Fstrong>@olympus.com\u003Cbr>Richard Reynolds, President, Olympus Corporation of the Americas, \u003Cstrong>(b)(6)\u003C\u002Fstrong>@olympus.com\u003Cbr>Hiroaki Hosoi, President, Aomori Olympus, \u003Cstrong>(b)(6)\u003C\u002Fstrong>@olympus.com\u003Cbr>Kota Ishibiki, President, Olympus Medical Systems Corporation \u003Cstrong>(b)(6)\u003C\u002Fstrong>@olympus.com\u003Cbr>Shinji Egami, Senior Director, Olympus Medical Systems Corporation, Hinode, \u003Cstrong>(b)(6)\u003C\u002Fstrong>@olympus.com\u003Cbr>Seiji Morishita, President, Shirakawa Olympus Co., Ltd., \u003Cstrong>(b)(6)\u003C\u002Fstrong>@olympus.com\u003Cbr>Carl A. Yallop, Vice President OSTE, SIS Operations & ISC and Managing Director, EMEA, \u003Cstrong>(b)(6)\u003C\u002Fstrong>@olympus.com\u003C\u002Fp>\n\n\n\n\n\n\n              \n                                            \n              \n            ","Delivery Method:\n\nVIA Electronic Mail\n\nProduct:\n\nMedical Devices\n\nRecipient:\n\nOlympus Medical Systems Corporation\n\n2951 Ishikawa-machi\n\nHachioji-shi, Tokyo\n\n192-8507\n\nJapan\n\n(b)(6)@olympus.com\n\nIssuing Office:\n\nCenter for Devices and Radiological Health\n\nUnited States\n\nSecondary Issuing Offices\n\nUnited States\n\nWARNING LETTER\nCMS #729208\nOctober 7, 2026\nDear Mr. White:\nThe United States Food and Drug Administration (FDA) conducted the following inspections of your firm’s medical device facilities:\nOlympus Medical Systems Corporation, located at 2951 Ishikawa-Cho, Hachioji-Shi, Tokyo, JP 192-8507, FEI 3002807795, November 17, 2025, to November 21, 2025 (“Hachioji”)\nAomori Olympus Co., Ltd., located at 2-248-1 Okkonoki, Kuroishi-shi, Aomori, JP, 036-0357, FEI 3003995201, from November 4, 2025, to November 7, 2025 (“Aomori”)\nOlympus Medical Systems Corp. Hinode Plant, located at 34-3 Hirai, Hinode-Machi, Nishitama-Gun, Tokyo, JP, 190-0182, FEI 3003637092, from November 17, 2025, to November 21, 2025 (“Hinode”)\nShirakawa Olympus Co., Ltd., located at 3-1 Okamiyama, Odakura, Nishigo-Mura, Nishishirakawa-Gun, Fukushima, JP 961-8061, FEI 3002808148, November 10, 2025, to November 14, 2025 (“Shirakawa”)\nOlympus Winter & IBE Gmbh, located at Kuehnstrasse 61, Hamburg, DE 22045, FEI 3002807798, from November 10, 2025, to November 21, 2025 (“Hamburg”)\nGyrus ACMI, Inc. [dba Olympus Surgical Technologies (OSTA)], located at 9600 Louisiana Ave North, Brooklyn Park, MN 55445, FEI 3011050570, from October 6, 2025, to November 12, 2025 (“Brooklyn Park”)\nDuring these inspections, our investigators determined that your firm manufactures a variety of surgical and endotherapy devices, including but not limited to, hemostatic metal clips, sphincterotomes, cystoscopes, bronchoscopes, endoscopic distal covers, valves, and insufflators. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body.\nQuality System Regulation Violations\nThe above-referenced inspections revealed that the devices manufactured at the Hachioji, Aomori, Hinode, Shirakawa, Hamburg, and Brooklyn Park facilities are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. This nonconformity includes issues across the referenced inspected facilities, resulting in the distribution of nonconforming devices and significant risks to patients.\nA Form FDA 483 (FDA 483), List of Inspectional Observations, was issued to the Aomori facility on November 7, 2025, the Brooklyn Park facility on November 12, 2025, the Shirakawa facility on November 14, 2025, the Hachioji facility on November 21, 2025, the Hinode facility on November 21, 2025, and the Hamburg facility on November 21, 2025. We received responses concerning our investigator’s observations noted on these FDA 483s from Robert A. Fryc, Director, Global Quality Compliance, External Regulatory Communications, Olympus Corporation of the Americas, dated December 22, 2025, February 13, 2026, March 30, 2026, May 28, 2026, and July 31, 2026. We address these responses (collectively referred to as “your firm’s response”) below, in relation to each of the noted violations. These violations include, but are not limited to, the following:\nDesign Control Violations – Shirakawa, Aomori, Hamburg, and Hachioji facilities\n1. Failure to establish and maintain procedures for validating the device design to ensure that devices conform to defined user needs and intended uses and validation shall include testing of production units under actual or simulated use conditions, as required by 21 CFR 820.30(g). For example,\na. At the Shirakawa facility, your firm failed to identify and control known catastrophic hazards in your risk management documentation and failed to validate the device design under actual or simulated use conditions for the UHI-4 insufflator. Catastrophic hazards, including air embolism, arrhythmia, and patient death, were identified through Health Hazard Assessments and complaint investigations associated with CAPA-201353; however, your Risk Management Report (DC00067142, dated November 6, 2025) did not reflect these hazards or ensure implementation of appropriate risk control measures, even after a confirmed patient death and Class I recall of UHI-4 units in 2023. Further, your design validation did not simulate actual or worst-case use conditions related to pressure sensor failure or inaccurate pressure measurements to ensure that the device would operate safely. As a result, devices distributed had design deficiencies that contributed to overpressure events during clinical use.\nThe adequacy of your firm’s response cannot be determined. Your response states that design-related deficiencies are being addressed through global CAPAs, including CAPA-204150 (design control) and CAPA-203525 (risk management), and that a traceability matrix for the UHI-4 will be developed to evaluate design requirements, verification, and validation. You also indicate that additional design verification and\u002For validation testing will be performed as needed and that potential design changes will be assessed by the design owner (Olympus Hachioji). However, these activities remain ongoing, and you have not provided objective evidence demonstrating that design validation deficiencies have been corrected or that revised validation activities adequately address identified risks, including overpressure conditions. Additionally, corrective actions have been deferred to global CAPAs and another facility, and no documentation has been provided demonstrating completion or effectiveness of these actions.\nb. At the Aomori facility, your firm failed to identify and assess known hazards in the risk management documentation and failed to establish risk control measures for manufacturing processes for the Sphincterotome. In your risk management report (E_V-KD_Risk Management Report_Rev.27), the corresponding risk line ID (KD-G158-00) identifies the potential patient harm as “Delay in Treatment” for complaints of deformed wires but fails to include the higher risk identified through analysis of Medical Device Reports of unintended cutting of blood vessels leading to patient bleeding. It also fails to identify any risk control measures for the manufacture of the wire for the Sphincterotome. Additionally, the risk management report (DC00609260_20250910) does not include the known hazard of failure of the Automated Optical Inspection system to detect nonconforming Sphincterotome products (KD-V400 Series) with burrs and flakes and does not include risk control measures for this hazard, which can lead to tissue damage and procedural complications.\nThe adequacy of your firm’s response cannot be determined at this time. Your firm has not provided an updated Risk Management Report (DC00609260_20250910) to address the hazard and implement risk control measures for failure of the Automated Optical Inspection system to detect nonconforming Sphincterotome products (KD-V400 Series) with burrs and flakes. Additionally, your firm has not provided an updated risk management report (E_V-KD_Risk Management Report) to address the risk of unintended cutting of blood vessels leading to patient bleeding and risk control measures for manufacture of the wire.\nc. At the Hamburg facility, your firm distributed the Continuous Flow Cystoscope (model WA22810A) with instructions for use (IFU) that claimed compatibility with the GreenLight PV ADDstat laser fiber component without conducting design validation testing to ensure compatibility under use conditions. This resulted in two recalls, RES 95584 and RES 98300, due to a risk of damage and\u002For overheating to the tip of the sheath when used together. Unrecognized sheath damage can result in tissue injury or parts of the sheath breaking off into the patient.\nThe adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. Your response should include a retrospective review of similar devices with IFU compatibility claims to ensure that they are supported by design validation activities to ensure compatibility under use conditions.\nd. At the Hachioji facility:\ni. Your firm distributed the BF-1TH190 bronchoscope with instructions for use (IFU) claiming compatibility with CO2 lasers without conducting design validation testing to ensure compatibility under use conditions. This resulted in a class I recall (RES 93052), due to a risk of endobronchial combustion if high-frequency cauterization is performed while supplying oxygen and\u002For the electrode section of the electrosurgical accessory is too close to the distal end of the endoscope. If endobronchial combustion occurs, the patient may suffer adverse events, including internal burns in their airway or lungs. The related CAPA did not evaluate compatibility claims for all endoscopes and lasers.\nii. Design validation activities were not conducted with an understanding of the actual operating conditions for the Evis Exera Video Imaging System, used with your firm’s endoscopes for processing images. For example, design validation did not consider the conductivity of the electrolyte when it contained dust and moisture, nor did it consider the impact over time of water entering the scope during cleaning. This caused signal transmission problems and resulted in a significant number of complaints and MDRs for image erasure, image transition problems, and poor-quality images.\niii. Your firm failed to complete design verification testing after implementing a change to the 0.2 μm Water Filter (Part MAJ-2318) to demonstrate that the device meets established design requirements and acceptance criteria. This water filter is used in your OER-Elite and OER-Mini Reprocessors for cleaning and high-level disinfection of your flexible endoscopes, their accessories, and endoscope reprocessor accessories. Your firm’s design change control procedure, OMBS_S_7.3.9_01_001, requires design verification or validation for all changes. However, ECR ER00006389 (dated December 11, 2024) shows verification testing was incomplete. Document MAJ-318_DC00429244 establishes the requirements and acceptance criteria for the product, including a filter service life of at least one month; however, design verification and validation records did not demonstrate that the filter has a service life of at least one month.\niv. Your firm’s design change control procedure, OMBS_S_7.3.9_01_001, and Traceability Activities (OMBS W_7.3.3_03_002) require documentation of design traceability matrices. However, you have not implemented design traceability matrices for the following products: Evis Exera III Bronchovideoscopes, Evis Exera III Video System Center, Evis X1 Video System Center, Single Use Reloadable Clip Applicator, Endoscope Reprocessor, Evis Exera III Duodenovideoscopes. Without design traceability matrices there is no documentation demonstrating that all design requirements, including safety requirements, were properly verified and validated.\nThe adequacy of your firm’s response for (i) through (iv) above cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness.\nNonconforming Product Violations – Brooklyn Park and Hinode facilities:\n2. Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90(a). For example,\na. At the Brooklyn Park facility,\ni. Your firm reworked and distributed nonconforming Vizishot 2 FLEX (19G) devices without adequate justification that the rework addressed the cause of the nonconformance. NCR-00038111 was opened on July 30, 2025, to disposition nonconforming material subject to recall (RES 97303) for the detachment of the Vizishot 2 Flex 19G needle [laser cut hypotube (LCH)] after reported complaints and MDRs, including where the device may have contributed to a patient death during explant surgery to recover the detached needle. Your firm reworked product under NCR-00038111 and dispositioned passing products using an automated vision system for release, stating this minimized impact on any product safety, efficacy, or performance of the product\u002Fmaterial. However, the primary CAPA for the LCH ejection issues had not identified a root cause, and there were two additional CAPAs open related to the observed complaints (pebax material degradation and sheath snap lock not engaging), indicating other potential contributing factors to nonconformances. Additionally, your firm circumvented the ship hold in place under the NCR by changing the manufacturing date during rework, which allowed the release of those units.\nThe adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. CAPA-203864 was opened and determined that the issue was linked to global processes GSOP‑00022 Global NC Management and GSOP‑00023 Global CAPA Management. The process related aspects of this observation are being addressed separately under Global CAPAs, CAPA-203799 and CAPA-204047. Your response acknowledged in CAPA 203864 that the eleven lots of product noted in NCR-00038111 underwent rework outside of your procedures. You reinstated the ship hold and quarantined all Vizishot 2 FLEX product. You executed product removal activities separately for Vizishot 2 FLEX (19G) devices, including a global removal decision made on December 11, 2025, with a corresponding 806 report submitted to FDA. Your firm’s corrective actions are ongoing under CAPA-203864, CAPA-203799 and CAPA-204047.\nii. Your firm failed to control all nonconforming Shockpulse Lithotripsy generators that were subject to recall due to a miswired component (RES 98360). NCR-00000670 was opened on June 1, 2022, to scope the units affected under recall FY23-OSTA-05, for the miswiring of the Shockpulse generator. This NCR did not include a scope of all affected devices, including 2 lots containing 21 and 25 sub-assemblies, 9 finished units, and 2 service units. NCR-00046008 was opened to address the scoping nonconformance.\nThe adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. CAPA-203777 was opened and the root cause identified the need to evaluate process gaps in Global Nonconformance Management GSOP-00022, specifically related to scoping methodology, alignment with HHA\u002FFCA teams, and decision-making during NCR and Stop Ship activities. A Global Ship Hold for miswired ShockPulse generator units was initiated on November 12, 2025, and the recall scope was expanded on December 9, 2025, with an 806 report submitted to FDA. Your firm’s corrective actions are ongoing under CAPA-203777 and CAPA-204047.\nb. At the Hinode facility,\ni. Your firm failed to control nonconforming MAJ 210 single-use biopsy valves when devices failed durability testing during the investigation of CAPA 203270. This CAPA was initiated after receiving multiple complaints reporting fractures of the device, including MDR reportable events. Although devices failed testing during the complaint investigation, your firm did not initiate a nonconformance for these out-of-specification device failures. Your firm eventually initiated NCR-00030581 for the complaint trend, but not for the identified testing failures.\nWe reviewed your firm’s response and determined that it is not adequate. Your firm has initiated actions to address the MAJ-210 failures, including a shipping hold on the device, a plan to modify the device design, and an investigation into the complaint trend. Your response does not address why a nonconformance was not initiated when testing showed the product\u002Ffailed the durability specification per GSOP-00029 Global Complaint Investigation and was only later opened for the complaint trend. It is unclear if you plan to evaluate whether similar issues occurred for other devices and how you will ensure that complaint investigations result in CAPAs when appropriate.\nii. Your firm failed to control nonconforming devices with sterile barrier seal overlap defects that were found to impact seal integrity. A nonconformance (NCR-00025684) was initiated in March 2025 in response to observed defects in sterile seals from September 2024- January 2025. NCR-00025684 identified overlaps as a novel defect that was not included in your visual inspection procedures. CAPA-202690 concluded that because seal overlaps are a large wrinkle, inspectors trained to visually identify wrinkles would identify seal overlap defects. However, wrinkles and seal overlaps represent distinct sterile barrier defects. CAPA-203907 included a retrospective evaluation to demonstrate that existing visual inspection procedures were likely to identify seal overlaps, based on a blind test of engineers. However, this evaluation does not demonstrate that overlaps were identified at the time of the nonconformances.\nWe reviewed your firm’s response and determined that it is not adequate. You state that you are conducting an investigation and root cause analysis as part of your CAPA; however, this is in progress and the details of this investigation and corrective actions are not clear, and you have not yet provided objective evidence demonstrating completion or effectiveness.\nProduction and Process Controls Violations – Brooklyn Park, Hinode, Aomori, and Shirakawa facilities\n3. Failure to adequately ensure that when the results of a process cannot be fully verified by subsequent inspection and test that the process shall be validated with a high degree of assurance and approved according to established procedure, as required by 21 CFR 820.75(a). For example,\na. At the Brooklyn Park facility,\ni. Your firm failed to validate the heat sealing process for the (b)(4) Tray Sealer. The (b)(4) Tray Sealer (P4001467-001 Gyrus ACMI SN:01) Operational Qualification using Universal tray sealing nests, documented in Operational Qualification (OQ) Report D8201348-002 Rev AB, does not contain passing results for the challenge conditions at the high and low setpoints. The validation was intended to cover low setpoints of 200°F, 100 PSI, and 2.0 seconds and high setpoints of 265°F, 125 PSI, and 7.0 seconds. However, visual results showed all failures at the lower setpoints and all failures at the high setpoints for the Universal and PKS Omni products. Only the nominal settings (232°F, 115 PSI, 4.5 seconds) showed passing results, which do not match your current production setpoints (253°F, 118 PSI, 4 seconds).\nDuring the inspection, you re-executed the validation (D8201348-002, Revision AC). While this validation passed seal integrity and seal strength requirements at high and low challenge conditions, the deviation section notes that trays sealed at low settings had spottiness in the seal and trays from high settings had warp that would cause rejection during 100% visual inspection, demonstrating that the process is not capable of consistently producing conforming product throughout the acceptable setpoint ranges.\nThe adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. You are in the process of implementing CAPA-203841 to address the root cause of inadequate process for assessing procedure revisions that resulted in earlier validations (Operational Qualifications) not being updated to meet regulatory requirements. Specifically, you plan to transition from Process Validation GSOP-7.5-1 to Global Process Validation GSOP-00002. Your response indicates that the retrospective re-validation of the heat sealers is complete except for the (b)(4) sealer for the Universal Tray products and the (b)(4) sealer for the Powerseal vessel sealing product line. You are currently assessing the risks associated with products manufactured and distributed using the (b)(4) Tray Sealer, which failed the retrospective re-validation. Regarding the retrospective revalidation of the (b)(4) heat sealer used for the Powerseal product line you have noted the OQ failed to meet seal width acceptance criteria as detailed in the protocol, however, the OQ\u002FPQ testing will not be repeated at the current process settings (temperature, time, pressure). You have indicated that you will communicate with FDA regarding any actions taken based on the outcome of the completed HHA for distributed product and failed retrospective revalidation.\nii. Your firm failed to validate the heat sealing process for tray material PN0003356 (45cm PETG Tray line) on the (b)(4) sealer SN01. The OQ Report for (b)(4) BM3025-E2W2 for 45cm packaging (DN0010012) and PQ Report for BP (b)(4) BM3025-E2W2 for 45cm packaging (DN0010301) for this material and setpoints is for sealer (b)(4), which was decommissioned and removed from use in 2023. Your firm did not provide documentation showing this material was validated on the (b)(4) sealer or justification for equipment equivalency.\nIn addition, your procedure Process Confirmation for Sterile Barrier Sealing GWI-0704-07 Rev AE dated April 4, 2024, allows for abbreviated validation runs for \"equivalent or duplicate equipment.\" This procedure allows for equipment with the same manufacturer and model number to be considered equivalent, regardless of the year purchased or any other modifications made to the sealers. There is no additional justification or testing required to establish equivalency of the equipment.\nThe adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. You are in the process of implementing CAPA-203842 to address GWI-0704-07 REV AE, Process Confirmation for Sterile Barrier Sealing, and FM-7.4-3 REV AC, Sterile Barrier Sealing Confirmation, not aligning with GSOP-00002 REV AD, Validation Program, nor GSOP-7.5-1 REV BA, Process Validation. In addition, your response confirmed that the work instructions and form lacked objective evidence to justify equipment equivalency. You are in the process of completing a Health Hazard Assessment (HHA- FY26-071-A) to evaluate any risks associated with sterile barriers for distributed products.\niii. Your firm failed to operate your heat sealers at the validated setpoints used for the Powerseal vessel sealing products. Heat sealer numbers 19-11821 and 23-70915 are only calibrated for time at 5 seconds and 10 seconds, but the nominal setpoint is 3 seconds according to your procedure POWERSEAL MP: Tray Sealer Setup and Peel Test DN0044870 Rev AE. There is no documented justification on why this calibration is acceptable to demonstrate accuracy at the validated setpoint, or potential impact on packaging seal quality and sterile barrier integrity for the Powerseal products.\nThe adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. For example, GSOP-7.18-1 REV AT, Control of Inspection, Measuring, and Test Equipment, does not ensure consistent implementation of calibration across the intended use range. Additionally, the supporting work instruction, GWI-0718-03 Rev AB Completing a Calibration Request Form, lacked sufficient clarity to implement the requirements of GSOP-7.18-1. Your firm plans to revise GWI-0718-03 to improve clarity, include a requirement to notify external calibration vendors of specification changes, and ensure calibration point selection is documented with clear rationale. The calibration request form (FM 7.18-1) will also be updated to provide traceability, reference the revised work instruction, and ensure alignment with validated set points. GSOP-7.18-1 will be updated to explicitly require calibration points to cover validated set points, document rationale for selected calibration points, and mandate re-evaluation of calibration points when validation parameters or process conditions change.\nb. At the Hinode facility, your firm failed to adequately validate critical process parameters of the (b)(4) to the heat sealing process. An Operational Qualification (OQ) for the heat sealing process for the MAJ-210 Single Use Biopsy valve was conducted in July 2024, after (b)(4) to the heat sealing packaging process to address seal wrinkle defects; however, the process parameters and validation are inadequate. The process parameter range shown in the Operational Qualification lists a lower set value of (b)(4) liters\u002Fminute and a higher set value of (b)(4) liters\u002Fminute, which is flawed because the \"lower\" limit exceeds the \"higher\" limit. The OQ documentation does not detail how the (b)(4).\nThe adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. Your firm completed an investigation and root cause analysis under CAPA-203908, and as a result, updated GSOP-00002 to provide instruction for how to identify process parameters that require control in a validated process. Your firm is also planning to conduct a review of all validated manufacturing processes in place at the facility to confirm that process parameters are adequately controlled.\nc. At the Aomori facility, your firm failed to validate the cleaning process for metal components used in the production of the HX-610 EZ Clip (hemostasis clip) made according to procedure DC00736661 to remove dirt or other particles. For example, the procedure doesn’t include defining and validating all critical process parameters with acceptable ranges including cleaning solution (type, concentration, temperature), immersion time, drying parameters, and visual inspection criteria.\nThe adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. Your firm initiated a Global Ship Hold (ID.530) and CAPA 203781 as part of your corrective actions.\nd. At the Shirakawa facility, your firm did not adequately validate the testing process used in the production of UHI-4 Insufflation Unit where the results could not be fully verified by subsequent inspection and testing. For example, the software-driven functional testing process used to evaluate device performance was not adequately validated to ensure that it consistently produced devices meeting specifications in that it did not include appropriate test cases to demonstrate user requirements met acceptance criteria.\nThe adequacy of your firm’s response cannot be determined. Your response states that process validation deficiencies are being addressed through ongoing remediation activities and global CAPA efforts, and that validation activities are planned or underway to ensure processes consistently produce conforming devices. You have not provided objective evidence demonstrating that process validation activities have been completed or that affected processes have been validated, including validation protocols, reports, or data demonstrating that processes consistently produce conforming devices.\n4. Failure to establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met, as required by 21 CFR 820.75(b). For example,\na. At the Brooklyn Park facility, your firm failed to establish adequate process monitoring to ensure validated sealing processes for the heat sealers used for the Powerseal vessel sealing and Miscellaneous Urology products continue to meet specifications throughout production. Per procedure Peel Strength Test Method for Trays and Pouches D5100327-001 Rev AL, the heat sealer for Powerseal products requires peel strength testing to be completed at the beginning and the end of a lot. The process monitoring does not demonstrate that the heat sealing meets specification throughout the manufacturing operations, nor does the process monitoring demonstrate the machine was fully set up and operational when heat sealing process for a lot occurs over multiple days. The DHR for Lot (b)(4) notes that the sealing took place over two days. However, the process monitoring was conducted according to the procedure and only had a single tray sealing sample for testing at the start of the lot on June 20, 2025, and at shutdown on June 23, 2025. Your firm’s procedure for set-up, “POWERSEAL MP: Tray Sealer Setup and Peel Test” DN0044870 Rev AE states in (b)(4) for the temperature to stabilize prior to use; however, there is no indication that this was done at the start of the second production day. This step is identified as critical, according to your firm’s Symbol Index in DN0044870. Additionally, the sealing procedure, D5100327-001, is also used for the Miscellaneous Urology line and the Cutting Forceps line and requires the pull strength testing be performed at the beginning and end of every day. Your firm has not assessed whether critical parameters remain in control during all production activities, including after equipment set up on subsequent production days and when processing multiple products with different configurations on the same day. Finally, your procedure Process Monitoring - Packaging Data Review D0300188-001 Rev AK states in section 4, step 2 that a process control analysis should include an evaluation of lower and upper control limits. However, these limits are not currently calculated by your firm, and the upper and lower bound specifications are used instead. There is no documented statistical rationale for this decision.\nThe adequacy of your response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. Your firm opened CAPA-203867 to capture corrective actions such as the retraining of employees on process monitoring requirements to include peel testing at the beginning and end of each lot for the affected product lines. You note that you will revise FM-7.5-10, Control Plan requirements with risk assessments to define and align appropriate sample sizes and frequency monitoring. Ongoing actions as part of CAPA-203867 include defining, establishing, and implementing risk-based requirements in Process Controls, GSOP-7.5-4, for ongoing validated process monitoring. You have not performed an assessment of potentially affected units in the field and any ongoing post market monitoring to assess any risks of commercially distributed product. Your firm plans to review all process monitoring plans subject to D0300188-001 Rev AK, to ensure that such plans include justified control limits as well as specification limits. Your firm has not implemented calculated control limits.\n5. Failure to ensure that when changes or process deviations occur, the manufacturer shall review and evaluate the process and perform revalidation where appropriate, as required by 21 CFR 820.75(c). For example,\na. At the Hinode facility, your firm failed to revalidate the heat sealing process after implementing process changes in response to seal defects in the MAJ-1555. CAPA-202690 identified the cause of the overlap defects as a misalignment of the bag surfaces when the bag enters the sealing operation to create the sterile barrier. To address this issue, your firm added a sensor to control opening and closing of the extraction arm and receiving arm, which impacts bag surface alignment during sealing. Operational qualification or performance qualification was not performed after these changes to validate that the modified process continued to meet specifications and quality attributes.\nThis is a repeat violation from our 2023 Warning Letter issued to the Hinode facility.\nThe adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. Following an investigation and root cause analysis under CAPA-203919, your firm revised GSOP-00002 to provide additional instruction on how to assess whether a manufacturing change triggers revalidation of the manufacturing process, and your firm established the guidance document GREF-00197 to provide revalidation guidelines. The verification of effectiveness of these actions is not yet complete, and it is unclear whether concerns with process validation have been adequately addressed for other products subject to sealing at your facility. Your response stated that all seals are subject to visual inspection and, therefore, any nonconforming seals would be detected prior to release; however, visual inspection is not a substitute for adequate process validation.\nCorrective and Preventive Action Violations – Brooklyn Park, Shirakawa, Hinode, Hachioji, Hamburg, and Aomori facilities:\n6. Failure to identify the action(s) needed to correct and prevent the recurrence of nonconforming product and other quality problems, as required by 21 CFR 820.100(a)(3). Specifically,\na. At the Brooklyn Park facility,\ni. Your firm failed to identify corrective actions that address the full scope of multiple Line Clearance Control nonconformances on the Miscellaneous Urology Production Line. CAPA-201354 was opened on August 31, 2023, and included automated verification steps and automated inspections on the lines. However, the CAPA only included implementing the automated verifications for the Soltive laser fibers and did not address corrections for any of the other products made on the Miscellaneous Urology production line, including nonconformances associated with missing syringes in the Irri-Flow line or incorrectly labeled RB Electrodes, as listed in the CAPA Initiation Information.\nThe adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. Your firm opened and is developing an action plan for CAPA-203705, which revealed that the Miscellaneous Urology product line lacks sufficient process controls and robust automation and further noted that this technical gap creates a potential for the recurrence of nonconformances. While a quality plan was developed per GSOP-5.5-1 Rev AB Quality Plans to address the remaining implementation requirements for this line, the execution of these corrective actions occurred outside of the formal CAPA framework and did not include verification of effectiveness.\nii. Your firm failed to identify corrective actions to address ongoing Supplier Quality Performance rate failures for Vizishot endoscopic aspiration needle slider components. CAPA-202086 was opened on August 15, 2024, to address the Supplier Quality Performance rate (SQ3) not meeting the KPI objective for more than three months in a row. The investigation identified root causes related to supplier capability gaps, including inadequate manufacturing processes, insufficient purchase order review, and delayed drawing revisions. A separate NCR-00028865 due to a SQ2 KPI signal (Part Failure Rate) was escalated to CAPA-202086 on May 20, 2025. CAPA-202086 was closed on October 16, 2025, with no corrective or preventive actions taken, and the SQ3 KPI was eliminated without addressing the underlying quality problems or providing a rationale for no action taken.\nThe adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. CAPA-203869 confirmed that the early closure of CAPA-202086 occurred because GSOP-00023, Rev AF Global Corrective Action and Preventive Action Management and GWI-00014, Rev AB CAPA Management Work Instruction – Agile did not clearly define requirements for early closure rationale or verification of linked records. An action plan is being developed but has not yet been implemented for CAPA-203869.\niii. Your firm identified a root cause for the blue ring on the Powerseal vessel sealing device detaching from the rotation knob during use (operator error during assembly) but failed to implement corrective actions consistent with that root cause. CAPA-200547 was opened on July 22, 2022, for the detachment, which resulted in a recall (RES 90788). The CAPA found the root cause was an operator error during assembly and not the out of specification supplier component originally documented in the HHA FY23-OSTA-07. However, the scope of corrections for the recall were based on supplier component lots and the scope was not expanded to include all devices assembled during the period when the operator error occurred, allowing potentially defective devices to remain in distribution.\nThe adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. Your firm opened CAPA-203868 and noted that the Health Hazard Assessment (HHA) and Field Corrective Action (FCA) for CAPA-200547 were not reassessed after the identified root cause changed, as procedure GSOP-00023 Rev AF Global Corrective Action and Preventive Action Management did not define requirements for re-evaluation when new investigation findings modify the identified failure mode. Your firm indicated that since the process is shared among sites, the process related aspects of this observation are being addressed separately under Global CAPA-203799. An action plan is being developed but has not yet been implemented for CAPA-203868.\nb. At the Shirakawa facility, your firm failed to identify corrective actions needed to correct and prevent the recurrence of known quality problems associated with the UHI-4 insufflation system. CAPA-200872 identified pressure sensor failures as the root cause of front panel display issues; however, you relied on prior corrective actions (SCAR-Shirakawa-152-06) and concluded that the risk remained acceptable despite 325 complaints. Your firm failed to implement adequate corrective actions to address supplier control failures, complaint trending deficiencies, and design and risk management process gaps that allowed these repeated failures. As a result, your supplier control processes failed to prevent defective components from entering production and your quality system failed to detect and escalate recurring defects.\nThe adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. Your response noted planned corrective actions, including reliance on global CAPA procedures (GSOP00023) and proposed improvements to complaint trending, supplier controls, and risk management processes. You indicated that CAPA deficiencies continue to be addressed through ongoing local and global CAPAs and that you have initiated additional CAPAs (e.g., CAPA-203879, CAPA-203856, CAPA-203877).\nc. At the Hinode facility, your firm’s CAPA procedures failed to ensure that corrective actions addressed the root causes and prevented recurrence. Between October 2022 and September 2025, three CAPAs (CAPA-200736, CAPA-201399, CAPA-203398) were opened for wrinkle defects in sterile barrier seals across five products (MAJ-2315, MAJ-1555, MAJ-209, MAJ-210, MAJ-287). Each CAPA identified inadequate process validation as a contributing factor, yet none implemented corrective actions to address the underlying validation methodology deficiency that allowed critical process parameters to be missed. For example, CAPA-203398 identified the root cause as \"Method Inadequate validation\" but did not implement corrective actions to address the validation failure. CAPA-201399 identified wrinkles across multiple products but concluded that inspection would remove nonconforming product, without implementing corrective actions to the validated processes producing defects. CAPA-200736 (b)(4) to address wrinkles but did not investigate why (b)(4) identified in initial validations. Wrinkle defects may create channels for microbial contamination.\nThe adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. Your firm characterized the pattern of recurring CAPAs for seal defects as representative of continuous improvement, citing decreases in defect rates, and your firm characterized the sealing processes as “under control”. However, ongoing nonconformances were initiated for wrinkles even after CAPAs were initiated. Your responses do not appear to address why your CAPA process allowed the same problem to require three separate CAPAs over three years without implementing corrections to the validation methodology.\nd. At the Hachioji facility, your firm failed to identify corrective actions for CAPA 201212, initiated June 20, 2023, in response to an FDA Additional Information request related to a patient death following use of the Evis Exera III Bronchovideoscope. Your CAPA documented that your firm failed to conduct design verification for use conditions and accessory compatibility claims in your IFU; however, no corrective actions were taken to address these design control deficiencies and the suspension of shipping was lifted on July 28, 2023. Your investigation revealed that your firm received 210 similar complaints and your investigation was not completed until November 14, 2025, over two years after CAPA initiation and your decision to continue shipping the devices.\nThe adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness.\n7. Failure to verify or validate the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device, as required by 21 CFR 820.100(a)(4). For example,\na. At the Brooklyn Park facility,\ni. Your firm implemented actions to address root causes of a Vizishot II component mix-up without classifying them as corrective actions and verifying their effectiveness. CAPA-203041 was opened on June 30, 2025, for the use of the 21G slider components instead of the 22G on the Vizishot II NA-U401SX-4022 line. The Early Closure memo states that “operators were retrained on the line clearance procedure GWI-0705-16 and (b)(4)” and “the (b)(4) was modified to restrict access to the sides…”. Neither of these actions were considered a corrective action, nor was a verification of effectiveness conducted to ensure these actions prevented recurrence of the component mix-up.\nThe adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. CAPA-203041 was prematurely closed because actions taken under the NCR were misclassified as corrections, even though they addressed root-cause-level factors that required corrective actions and verification of effectiveness (VOE). GSOP-00023 Rev AF Global Corrective Action and Preventive Action Management did not explicitly distinguish correction from corrective action within the CAPA workflow, which contributed to the omission of VOE. Your firm also indicated an action plan is being developed but has not yet been implemented for CAPA-203705.\nii. Your procedures, Quality Planning QSP-5.5 Rev AL and Quality Plans GSOP-5.5-1 Rev AB, have not adequately defined when quality plans contain corrective or preventive actions and should contain a verification that changes are effective and do not adversely affect devices. These procedures do not adequately define the difference between a quality plan and a corrective or preventive action. Additionally, during the inspection your firm had 54 quality plans open, including multiple plans intended to address backlogs in the complaint system and late MDRs. These quality plans directly address deficiencies in your quality system and are also being referenced within and in conjunction with CAPAs addressing the same issues.\nThe adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. CAPA-203836 determined that the current procedures lack defined criteria for determining when a Quality Plan is not appropriate and a CAPA is required and does not require oversight to ensure appropriate use and completion tracking of Quality Plans. The Quality Management Review Presentation Template GTMP-00077 was revised to require that quality plans be reviewed as part of the Quality Management Review process. The scope of affected quality plans that lacked VOE was not provided. An action plan is being developed but has not yet been implemented for CAPA-203836.\nb. At the Shirakawa facility, your firm failed to verify that corrective actions implemented for overpressure events for the UHI-4 Insufflator were effective in preventing recurrence. For example, CAPA-200872 (opened February 2023) relied on prior corrective actions related to pressure sensor failures and concluded that these actions were effective without demonstrating that they prevented recurrence of similar defects or adequately mitigated risk in distributed devices. CAPA-201353 (opened August 2023) was subsequently opened to address overpressure events associated with the UHI-4 insufflation system only after significant adverse events occurred, including cardiac arrest and possible gas embolism, and resulted in a Class I recall (RES 92932). Your CAPA activities did not demonstrate that corrective actions were verified or validated to ensure effectiveness in preventing recurrence of overpressure-related failures.\nThe adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. Several CAPAs remain open, and you have not demonstrated that corrective actions have been verified or validated to ensure effectiveness or to prevent recurrence of similar defects, including overpressure-related failures.\n8. Failure to analyze processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems, as required by 21 CFR 820.100(a)(1). For example,\na. At the Brooklyn Park facility, your firm is using statistical methods for complaint trending without a documented rationale for the appropriateness of those methods. Complaint Trending Attributes, Statistical Method, and Trending Rules GREF-00157 Rev AA defines your complaint quality data analysis method of using median values and recalculating control limits each month. During the inspection your employees noted the calculations used were originally chosen in 2020, due to COVID-related data irregularities. However, you acknowledged that your firm does not still see these data irregularities and confirmed your firm has not documented a re-assessment or other justification for why this analysis method is still appropriate. The use of median values and monthly recalculation of control limits (that may not be appropriate for post-COVID data) may mask trends or delay detection of increasing complaint rates, potentially allowing serious device problems to persist undetected.\nThe adequacy of your firm’s response cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. CAPA-203873 determined that Olympus lacks a global procedure or guidance for statistical techniques, resulting in the absence of defined expectations for the consistent implementation of statistical methods. An action plan is being developed but has not yet been implemented for CAPA-203873.\nb. At the Shirakawa facility, your firm did not adequately analyze quality data, including complaints and adverse event information, to identify causes of quality problems. For example, you received a high volume of complaints related to pressure sensor defects and front panel failures associated with the UHI-4 insufflation system (including 325 complaints between November 2020 and October 2022), yet you did not appropriately trend or escalate these data to identify a cause or initiate CAPA in a timely manner. Additionally, you were aware of pressure sensor defects as early as 2018–2021 but did not reassess risk or investigate the increased occurrence of these defects in distributed devices. A CAPA was not initiated until FDA inquiry, indicating that your quality system did not effectively analyze available data sources, including complaints, supplier information, and risk management records.\nWe reviewed your firm’s response and determined that it is not adequate. Your response states that CAPA deficiencies are being addressed through a combination of local and global CAPAs, including local CAPA-203879, CAPA-203856, CAPA-203850, and global CAPA-203789, CAPA-203525, and CAPA-204150. You indicate that updates to procedures, including GSOP-00023 (CAPA), GSOP-00033 (complaint trending), GSOP-00069 (supplier quality agreement), and GSOP-00079 (supplier corrective action), have been implemented or are in progress. You also state that retrospective reviews of complaint data and supplier corrective action requests have been conducted. Several CAPAs remain open and root cause investigations and corrective actions are ongoing. Additionally, you indicate that certain local CAPAs will be closed early and that corrective actions will be addressed under global CAPAs, which limits the ability to assess whether site-specific deficiencies have been adequately addressed. Your response further confirms that complaint trend signals were not adequately identified and that supplier-related defects were not appropriately evaluated for field impact at the time they were identified. You have not provided sufficient objective evidence demonstrating implementation or effectiveness of corrective actions, including completion of investigations, verification of corrective actions, or sustained improvements to your CAPA system.\nc. At the Hamburg facility, your firm’s complaint trending failed to include all complaints as required by your procedure. Trending Attributes, Statistical Method, and Trending Rules GREF-00157 Rev AA, section 4.4.2 states “trending will be based on the value of monthly data (i.e. actual number of open complaints per month).” However, trend signal information (TS-1224-WA50042A) for your video telescope (model WA50042A) only includes the trending of MDR reportable complaints and does not include non-reportable complaints.\nWe reviewed your firm’s response and determined that it is not adequate. Your response did not include an assessment of how the lack of trending of non-reportable complaints may impact already distributed product. For example, if the complaints reveal quality problems that may require correction or removal to address.\nd. At the Aomori facility,\ni. Your firm failed to adequately analyze quality data to identify causes of nonconforming product. CAPA-201434, which was initiated to address reports of deformed wires for the Single Use 3-Lumen Sphincterotome, incorrectly identified the root cause as “shortcomings in work procedures” during outsourcing, failing to recognize inadequate design transfer to production specification as the actual cause. Per the CAPA scope, the corrective actions only applied to products distributed to the Japanese market and were not implemented for devices distributed to the U.S. market. It was noted during the inspection that the CAPA task (Task 10012651) assigned to correct the manufacturing process for products destined for the U.S. was cancelled because the products are subject to FDA 510(k) and it would have taken longer to implement the changes which would “prolong the period until the CAPA closes.” Your firm received over 1000 complaints for this device failure, including 24 MDR reportable events.\nii. Your firm failed to conduct a timely and adequate analysis of complaint data related to potential causes of nonconforming product for the Thunderbeat 5 mm Front-actuated Grip Type S. Your firm received over 1900 complaints between September 2021 and September 2024, including 1583 that were MDR reportable. CAPA-201438 was initiated on October 18, 2023, but no action was taken as the Health Hazard Evaluation was canceled on January 31, 2024, because it was deemed not necessary based on complaint incident rates and without considering the potential harm to patients. A recall (RES 95950) was initiated on November 25, 2024, over a year later.\nThe adequacy of your firm’s response for (i) and (ii) above cannot be determined at this time. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness.\nAcceptance Activities Violations – Brooklyn Park and Shirakawa facilities:\n9. Failure to establish and maintain procedures for acceptance of incoming product, as required by 21 CFR 820.80(b). For example,\na. At the Brooklyn Park facility, your firm failed to conduct statistical calculations required to demonstrate lot acceptability in accordance with your procedure. Receiving Acceptance GSOP-7.11-1 Rev AT uses a variable sampling plan for receiving inspection of part number 0000315-TAB, according to Inspection Procedure for 0000315-TAB JAW ASSEMBLY, MACHINED, INNER, POWERSEAL CURVED JAW B DN0040655 Rev AE. However, your receiving inspection for each length of this part (PN 0000315-001, 0000315-002 and 0000315-003) does not include calculation of your standard deviation, kLSL, and kUSL as required by GSOP-7.11-1. Additionally, your acceptance procedure for Powerseal Curved Jaw B only includes a specification for sample calculation for dimension 9 but does not document a calculation of the maximum standard deviation (MSD) for any other dimension as required. Finally, your Supplier D also uses the sampling plan, but does not provide you with their standard deviation, kLSL and kUSL calculations. The calculations for standard deviation, lower controls limits and upper control limits are part of the variable sampling plan that demonstrate the acceptability of the lot.\nYour inspection procedure also allows for CMM measurements to be re-tested by another inspector if they do not pass initially. This was done for 8 of the 10 samples in the FAI Inspection Request for part number 0000315-002, dated March 20, 2025. The only rationale recorded was \"Believed fixture incorrect.\" Our inspection also found that retesting had occurred on all of the most recent receiving records for all sizes of the 000315-TAB. Part Number 0000315-001 was inspected on October 23, 2025, and the record includes failing CMM results for 5 of the 10 parts, as well as the retested data, but the parts were accepted into inventory. When our investigator communicated this to your employee, it was noted that this lot was accepted by mistake and NCR-00048701 was opened to contain the nonconforming material.\nWe reviewed your firm’s response and determined that it is not adequate. CAPA-203866 was opened to capture corrective actions and noted that GSOP 7.11-1 Rev. AU, Receiving Acceptance, and the inspection procedures did not define the statistical requirements, resulting in incomplete evaluation of incoming product and acceptance of parts without proper statistical justification. Your response noted that you have updated the inspection procedures for all parts subject to ANSI\u002FASQ Z1.9 to require inclusion of sample size rationale for critical dimensions and to ensure that data is provided by their suppliers. Your firm plans to conduct a retrospective review of inspection records from the past 2 years for failed dimensions without a record of appropriate retest or passing results. Based on the results of the review you will take appropriate action; however, it is not clear what those actions would include, nor if the actions will include a risk assessment for product that has been distributed.\nb. At the Shirakawa facility, your firm failed to identify defective components used in the UHI-4 insufflation system during acceptance activities. For example, defective pressure sensor components were not identified through incoming inspection or acceptance testing prior to use in manufacturing. As a result, nonconforming components were incorporated into finished devices, contributing to reports of device malfunctions and adverse events received by your firm.\nThe adequacy of your firm’s response cannot be determined. Your corrections remain ongoing, and you have not yet provided objective evidence demonstrating completion or effectiveness. Your response states that improvements to incoming acceptance activities will be implemented as part of broader corrective actions, including updates to ensure that purchased materials meet specifications. However, you have not provided sufficient detail demonstrating that revised acceptance activities have been implemented or are effective in detecting nonconforming components.\nPurchasing Controls Violations – Brooklyn Park, Shirakawa and Hamburg facilities:\n10. Failure to establish and maintain procedures to ensure that all purchased or otherwise received product, and services conform to specified requirements, as required by 21 CFR 820.50. For example,\na. At the Brooklyn Park facility,\ni. Your firm’s supplier controls procedure (GQS-00013) does not ensure that supplied product that cannot be fully verified by subsequent inspection and test is validated with a high degree of assurance and conforms to specified requirements. On December 4, 2023, your firm issued SCR-0000649 for an increased rate of complaints for broken welds in the ESG PK Cutting Forceps (model PK-CF0533), occurring in the supplied bottom and top jaw assemblies (part numbers P5700259-001 and P5700260-001, respectively). Supplier A determined the cause of the weld breaking was a sub-supplier, Supplier B. In SCR-0000649, Supplier A documented that Supplier B stated the welding process \"could not be controlled or validated.\" Your firm established increased inspection rather than requiring validation or changing suppliers. This complaint trend resulted in a recall (RES 93842) in December 2023. This unvalidated welding process has resulted in weld failures during patient use, creating risk of foreign bodies in patients assessed at Critical (S4) severity and High (S5) probability. Similar welds are also performed by Supplier B for your Halo and Cutting Forceps. Approximately 4,600 units with similar unvalidated welds have been distributed. During the inspection, your firm initiated an NCR and a Global Ship Hold.\nWe reviewed your firm’s response and determined that it is not adequate. CAPA-203871 was opened to address the failure to ensure welding performed by the supplier was validated. The CAPA root cause investigation identified that the QAA template used to finalize the Supplier Agreement back in 2014 did not incorporate process validation requirements for suppliers and their Sub-Tier suppliers. Moreover, the Global QAA templates GTMP-00021 Rev AB QAA Template for Component Suppliers and GTMP-00022 Rev AB QAA Template for Finished Device Suppliers lack specificity on sub-tier control for process validation. All impacted product remains on Global Ship Hold (ID 476), and you have halted the manufacture of affected product. The FCA board reviewed and decided to conduct a removal of the impacted products. Your response stated you would submit a Correction and Removal report in compliance with 21 CFR Part 806 requirements. Although an expansion of the recall is being performed, it has been over 2 years between awareness (December 4, 2023) and recall decision (February 3, 2026). Your firm has not explained the delay or assessed patient harm during this period.\nii. Your firm accepted failing process capability data after components were remeasured without justification. SCR-0000166 was issued to Supplier C for out of specification components. The investigation led to two design changes to the mating parts used in the Powerseal vessel sealing device: the blue ring (part PN0013810) and the overmolded rotation knob (part PN0013804) and resulted in a class II recall (RES 90788). You accepted first article inspection that included Supplier C “Validation Documents Submission” where parts were remeasured with passing results, “Ppk’s for Cav 2 on PQ1 was right at 1.39 and PQ2 was 1.36 failing the Ppk requirement per protocol of 1.39. 2 parts were remeasured and Ppk came into requirement.” There is no justification for why these remeasurements were considered appropriate.\nWe reviewed your firm’s response and determined that it is not adequate. CAPA-203872 is ongoing, and the root cause investigation identified that the supplier procedure permitted data remeasurement without documented justification and did not define requirements for documenting the rationale or controls associated with remeasurement activities. In addition, GSOP-00086 Rev AA Global External Product Qualification lacked requirements for justification of remeasurement. Your firm’s response notes that you have planned the process to requalify Supplier C against new global procedure requirements by March 27, 2026, including a new Quality Agreement. The impact on released product has not been evaluated since this will involve the remeasurement at incoming testing after you have updated GSOP-00086 that governs the conditions and permissibility for remeasurement. Your firm has not provided interim results or identified how many additional components may be affected. Your response should also include a retrospective review of similar supplier processes that pose a potential for patient safety risk.\niii. Section 3.5 of First Article Inspection GSOP-7.11-2 Rev AG, allows suppliers on risk improvement plans with documented quality concerns to conduct first article inspections without additional verification by your firm. For example, Supplier D has been on a risk improvement plan since January 21, 2025, but a \"Supplier conducted FAI\" for part number 0000315-002, delivered on or before March 5, 2025, and used in the Powerseal vessel sealing device. The process is currently controlled by the two procedures Global Supplier Risk Improvement GSOP-00045 Rev AB and Global Supplier Risk Improvement with Action Plan GWI-00002 Rev AB. Despite the supplier providing out-of-specification components and being on a supplier risk improvement plan, your firm failed to consider the appropriateness of the supplier performing first article inspection measurements following a design change or when implementing a new component.\nWe reviewed your firm’s response and determined that it is not adequate. CAPA-203866 identified that GSOP-00045 Rev AB Global Supplier Risk Improvement does not require evaluation of internal inspection plans when supplier risk improvement plans are issued or revised in response to changes in part failure rate. Additionally, the procedure lacks defined linkage between supplier risk improvement plans and corresponding receiving inspection requirements. It is not clear from your response whether there is nonconforming product in the field associated with suppliers who are on a heightened inspection status or risk improvement plan and who conducted their own supplier first article inspections.\niv. Supplier A has not adequately validated their Performance Qualification Report PQR-10774 Rev A for part number P5700138-001, used to support the weld tensile strength in your legacy Cutting Forceps. According to your firm’s Engineer, the worst-case weld is considered the shortest weld of the group, as the welds all have to meet a minimum weld pull strength of 30 lbs. However, part P5700138-001 has a weld length specification of 0.10 ± 0.02 inches, while parts P5700211-002 and P5700210-002 have a shorter weld length specification of 0.081 ± 0.02 inches.\nWe reviewed your firm’s response and determined that it is not adequate. CAPA-203871 was opened and a Health Hazard Assessment (HHA) FY26-062 was conducted to evaluate potential field action. On February 3, 2026, the FCA board reviewed and decided to conduct a removal of the impacted products in the Cutting Forceps product line (RES 98454). Olympus completed the review of validations for Supplier A to determine conformance with Global GSOP-00002 Rev AD Validation Program and GWI-00112 Rev AA Global Standards for External Product Qualification for worst-case trials with documented rationale. The review determined that three (3) components manufactured by Supplier A require additional process validation. The review, however, was limited to products with an active production schedule. Products that have reached end-of-life and are in the process to be discontinued were excluded from the scope (jaw assemblies, ESG Cutting Forceps, Halo, Everest 5mm Cutting Forceps, and PKS Cutting Forceps). It is not clear from your response whether there is product within expiry date that is still in commercial distribution. Your firm will complete a review of applicable supplier-manufactured components documentation, through collaboration with suppliers to identify potential validation gaps.\nb. At the Shirakawa facility, your firm did not adequately control suppliers to ensure that components used in the UHI-4 insufflation system met specified requirements. For example, pressure sensor defects associated with supplier-provided components were identified; however, your supplier control processes did not prevent nonconforming components from being incorporated into finished devices. Your CAPA investigations did not adequately evaluate why supplier controls were ineffective or ensure that appropriate corrective actions were implemented to prevent recurrence of similar supplier-related defects. Root cause analysis identified gaps in supplier change control procedures and audit processes, including lack of mechanisms to verify supplier changes against specifications.\nThe adequacy of your firm’s response cannot be determined. Your response states that supplier control deficiencies are being addressed through local and global CAPAs, including CAPA-203856 and CAPA-203789, and that supplier oversight processes will be enhanced through updated supplier quality agreements and risk-based supplier requalification activities. You also indicate that procedures, including GSOP-00079, have been updated to require assessment of field impact for supplier-related defects. However, investigations into supplier-related root causes remain ongoing, and corrective actions have not been fully implemented. Additionally, you indicate that certain local CAPAs will be closed early and that corrective actions will be addressed under global CAPAs, which limits the ability to assess whether site-specific supplier control deficiencies have been adequately addressed. You have not provided objective evidence demonstrating that revised supplier controls are effective in preventing recurrence of nonconforming components.\nc. At the Hamburg facility, your firm failed to ensure that purchased services conform to specified requirements. Your firm hired HCL Technologies as part of “(b)(4)” to reduce the backlog of complaint investigation and closures; however, your firm did not evaluate HCL Technologies on the basis of their ability to provide contract services to meet specified quality requirements, including their ability to provide qualified staff to perform quality assurance responsibilities. Your firm’s contract services included approximately (b)(4) temporary personnel to investigate and close complaint files. Your firm was unable to demonstrate that the contract personnel received product specific training.\nWe reviewed your firm’s response and determined that it is not adequate. Your firm initiated CAPA-204033 and CAPA-204034. Your firm indicated that your root cause investigation determined that there was no central governance defining shared services requirements within the Quality Management System (QMS) and that as a result, roles and responsibilities between Legal Manufacturers, Global QMS functions, and shared service owners were not consistently defined or understood, leading to fragmented accountability for end-to-end oversight. Your firm is developing a corrective action plan; however, you have not provided corrective actions demonstrating how you will ensure contract personnel are qualified and trained in the services they will perform.\nRecords Violations – Brooklyn Park and Shirakawa facilities:\n11. Failure to review, evaluate and investigate any complaint involving the possible failure of a device, labeling or packaging to meet any of its specifications, as required by 21 CFR 820.198(c). For example,\na. At the Brooklyn Park facility, your firm's procedure, Complaint Investigation Tiers and Investigation Activities GWI-0809-10 Rev BB, does not require investigations to be completed on complaints in investigation Tier 3. For example, complaints C22097460, C22184070, C22248777, C22249599, C22259835, C22279317, C22332770, and C22387391 all state in the investigation summary that the complaints are “non-PAE, Tier 3 codes. No investigation is required,” in the “Evaluation Result” section (PAE stands for potential adverse event). There is no documentation of a complaint investigation or reference to where an investigation for this failure has previously been investigated or other similar rationale for why this investigation is not required. Lack of investigation only allows trending on this subset of complaints based on date of receipt and device model. After transitioning to your current Trackwise system in November 2024, you indicate you no longer use a tier system; however, your trending is based on 24 months of historical data which is still limited by the lack of investigation results on potential device performance issues.\nWe reviewed your firm’s response and determined that it is not adequate. Your response does not address the failure to investigate complaints.\nb. At the Shirakawa facility, your firm failed to adequately investigate complaints involving serious adverse events to determine whether device malfunction contributed to the reported outcomes. For example, complaints associated with UHI-4 insufflation systems, including reports of overpressure events and serious adverse outcomes such as cardiac arrest and possible gas embolism, were not fully evaluated to determine whether device malfunction contributed to the reported events. Your complaint investigations did not consistently incorporate available device performance data to determine whether the device met specifications during use. For example, complaint CN-249953 reported a death due to gas embolism during use and included the device event log retrieved by the Field Service Engineer; however, this log was not reviewed as part of the investigation.\nWe reviewed your firm’s response and determined that it is not adequate. You state that complaint handling and trending processes have been improved through implementation of GSOP-00033 and that retrospective reviews of complaint data have been conducted to assess whether complaint signals were appropriately escalated. You also indicate that CAPA-203879 was initiated to address missed complaint trend signals. However, CAPA-203879 and related investigations remain ongoing, and you have not provided sufficient objective evidence demonstrating that complaint investigations are comprehensive or that systemic issues are consistently identified and escalated.\nMedical Device Reporting (MDR) Violations\nOur inspection at your Hamburg facility also revealed that your firm’s resection sets are misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), in that your firm failed or refused to furnish material or information respecting the device that is required by or under section 519 of the Act, 21 U.S.C. § 360i, and 21 CFR Part 803 - Medical Device Reporting. Significant violations include, but are not limited to, the following:\n12. Failure to report the information required by 21 CFR 803.52 in accordance with the requirements of 21 CFR 803.12(a), no later than 30 calendar days after the day that the firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that it markets has malfunctioned and this device or a similar device that the firm markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur, as required by 21 CFR 803.50(a)(2).\nFor example, the information included in Complaints CN-182867 and CN-184790 reasonably suggests that your firm’s resection set malfunctioned (e.g., broken ceramic insulation) while in use. A serious injury MDR 2951238-2019-00404, submitted by your firm on February 1, 2019, documents a serious injury resulting from the same malfunction involving the same device. That malfunction would be likely to cause or contribute to a death or serious injury if it were to recur, as evidenced by the serious injury MDR 2951238-2019-00404. Accordingly, the referenced adverse events represent MDR-reportable malfunctions as defined under 21 CFR 803.3. Your firm became aware of complaint CN-182867 on February 13, 2025, and submitted the corresponding MDR 9610773-2025-06509 on October 20, 2025; and became aware of CN-184790 on February 12, 2025, and submitted the corresponding MDR 9610773-2025-04016 on June 16, 2025. These two MDRs were submitted beyond the required 30-calendar-day reporting timeframe.\nThe adequacy of your firm’s response cannot be determined at this time. The response states that your firm initiated CAPA-204035 to address late reporting, including revising procedures to correctly document event dates and the dates your firm became aware of the events. However, supporting evidence demonstrating completion of these corrective actions was not provided because the corrective actions are still ongoing.\nFailure to address any violations of the FD&C Act may result in the FDA refusing admission of the devices manufactured by your firm into the United States under section 801(a) of the FD&C Act, 21 U.S.C. § 381(a). Devices under this authority that appear to be adulterated may be detained or refused admission.\nYour firm should provide a written response to this Warning Letter as described below and address the violations described in this letter. We will notify you regarding the adequacy of your firm’s responses and the need to re-inspect your firm’s facilities to verify that the appropriate corrections and\u002For corrective actions have been made.\nOther federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed.\nOn February 2, 2024, the FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities around the world. The revised part 820, referred to as the Quality Management System Regulation (QMSR), became effective on February 2, 2026. Your most recent inspections conducted between October 2025 and December 2025 were conducted pursuant to the QS Regulation, which was in effect at the time of the inspections. However, any corrective actions you propose or implement must be pursuant to the QMSR requirements in effect as of February 2, 2026. For more information on the QMSR please refer to our frequently asked questions webpage: https:\u002F\u002Fwww.fda.gov\u002Fmedical-devices\u002Fquality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp\u002Fquality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked.\nIn addition, we also note the following comments:\n1. In response to three prior warning letters issued to your firm in 2022 and 2023 (including the Hachioji and Hinode facilities), your firm implemented new global procedures, including complaint handling, MDR, and CAPA procedures. Review of these procedures found the roles and responsibilities of manufacturing sites versus your global remote corporate entity have not been clearly defined, including, for example, how your firm will assess that site specific quality issues have been resolved, and how your global CAPA process will provide oversight and ensure correction and prevention of repetitive quality issues within and across your global facilities that follow these procedures.\n2. Regarding the inspection of Olympus Corporation of the Americas, located at 3500 Corporate Pkwy, Center Valley, PA 18034, FEI 2429304, from November 18, 2025, to December 16, 2025: Multiple complaint files reviewed during the inspection were found to contain insufficient documentation of complaint intake, evaluation, and investigation conclusions. Complete complaint files provide your firm with critical information to detect and trend medical device failures and to make reportability decisions.\nPlease notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and\u002For corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and\u002For corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and\u002For corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Please provide a translation of documentation not in English to facilitate our review. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.\nYour firm’s response should be sent via email to Kristina Donohue at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS #729208” when replying. If you have any questions about the contents of this letter, please contact: Beckilyn Dorsey at Rebecca.dorsey@fda.hhs.gov.\nFinally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.\nSincerely,\n\u002FS\u002F\nMichael J. Hoffmann\nDirector\nOffice of Health Technologies 3 - Gastrorenal, ObGyn,\nGeneral Hospital, and Urology Devices\nOffice of Product Evaluation and Quality\nCenter for Devices and Radiological Health\nCC:\nTodd Brill, US Agent, Gyrus ACMI, Inc., (b)(6)@Olympus.com\nDaniel S. Sampson, Senior Director of Operations, (b)(6)@olympus.com\nRichard Reynolds, President, Olympus Corporation of the Americas, (b)(6)@olympus.com\nHiroaki Hosoi, President, Aomori Olympus, (b)(6)@olympus.com\nKota Ishibiki, President, Olympus Medical Systems Corporation (b)(6)@olympus.com\nShinji Egami, Senior Director, Olympus Medical Systems Corporation, Hinode, (b)(6)@olympus.com\nSeiji Morishita, President, Shirakawa Olympus Co., Ltd., (b)(6)@olympus.com\nCarl A. Yallop, Vice President OSTE, SIS Operations & ISC and Managing Director, EMEA, (b)(6)@olympus.com","2026-10-27T01:19:05.406+00:00",[22,23,24,9,10,25,25,25],"\u003Ctime datetime=\"2026-10-20T04:00:00Z\">10\u002F20\u002F2026\u003C\u002Ftime>\n","\u003Ctime datetime=\"2026-10-07T04:00:00Z\">10\u002F07\u002F2026\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Folympus-medical-systems-corporation-729208-10072026\">Olympus Medical Systems Corporation\u003C\u002Fa>","","2026-10-27T01:18:54.544251+00:00","2026-10-27T01:19:06.252428+00:00",{"510k":29,"classification":30,"enforcement":31,"event":32,"event_backfill":33,"pma":34,"warning_letter":35},"2026-10-26T02:00:44.031+00:00","2026-10-26T02:00:36.851+00:00","2026-10-26T02:00:41.561+00:00","2026-10-29T04:01:37.416+00:00","2026-09-07T05:17:28.839+00:00","2026-10-26T02:00:45.578+00:00","2026-10-27T01:19:46.805+00:00"]