[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-next-medical-products-company-llc-727918-08192026":3,"fda-latest-sync-dates":29},{"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":18,"recipient_title":8,"body_html":19,"body_text":20,"body_fetched_at":21,"medical_device_id":8,"raw":22,"created_at":27,"updated_at":28},22101,"next-medical-products-company-llc-727918-08192026","Warning Letter","Next Medical Products Company, LLC",null,"Center for Devices and Radiological Health","CGMP\u002FQSR\u002FMedical Devices\u002FAdulterated","2026-11-03","2026-08-19","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fnext-medical-products-company-llc-727918-08192026","727918","Medical Devices","VIA Electronic Mail","Ms. Julia M. Jacobson","\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>\n  \u003Cdiv>\n    \u003Cdiv>Recipient Name\u003C\u002Fdiv>\n              \u003Cdiv>Ms. Julia M. Jacobson\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                                \u003Cdd>\n  \u003Cdiv>\n    \u003Cdiv>Recipient Title\u003C\u002Fdiv>\n              \u003Cdiv>President and CEO\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Next Medical Products Company, LLC\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp>\u003Cspan>45 Columbia Road\u003C\u002Fspan>\u003Cbr>\n\u003Cspan>Branchburg\u003C\u002Fspan>, \u003Cspan>NJ\u003C\u002Fspan> \u003Cspan>08876\u003C\u002Fspan>\u003Cbr>\n\u003Cspan>United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n            \n            \u003Cdd>\n\n    \u003C\u002Fdd>\u003Cdd>\u003Cspan>\u003C\u002Fspan>\u003Ca href=\"mailto:(b)(6), (b)(7)(C)\"> (b)(6), (b)(7)(C)\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    \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 #727918\u003C\u002Fp>\u003Cp>August 19, 2026\u003C\u002Fp>\u003Cp>Dear Ms. Jacobson:\u003C\u002Fp>\u003Cp>During an inspection of your firm located in Branchburg, NJ from November 10, 2025 through December 10, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Clear Image Ultrasound Gel, Clear Image Sterile, non-sterile MediChoice Ultrasound Gel, and Clear Image Singles. 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 any function of the body.\u003C\u002Fp>\u003Cp>\u003Cstrong>\u003Cu>Quality System Regulation Violations\u003C\u002Fu>\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>This inspection revealed that these devices 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, \u003Cu>Code of Federal Regulations\u003C\u002Fu> (CFR), Part 820. We received responses from you dated January 2, 2026 and March 19, 2026 (responses), concerning our investigator observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to you on December 10, 2025. We address these responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:\u003C\u002Fp>\u003Cp>1. Failure to establish and maintain procedures where environmental conditions that could reasonably be expected to have an adverse effect on product quality, as required by 21 CFR 820.70(c). Specifically, “Quality Assurance Environmental Testing” procedure, Number 907-030, Revision 005 is not adequate in that:\u003C\u002Fp>\u003Cp>A. Section 2.0 of this procedure, which states “\u003Cstrong>(b)(4)\u003C\u002Fstrong> will be conducted \u003Cstrong>(b)(4)\u003C\u002Fstrong> on each packaging line. \u003Cstrong>(b)(4)\u003C\u002Fstrong>…” is not adequate. You have not demonstrated or justified why \u003Cstrong>(b)(4)\u003C\u002Fstrong> test result can be negated simply by \u003Cstrong>(b)(4)\u003C\u002Fstrong>. Further, your procedure does not require investigating failed test results nor does it address documenting a justification for the dismissal of the initial failed results. For example, your firm established environmental \u003Cstrong>(b)(4)\u003C\u002Fstrong> locations for Lots of Clear Image Ultrasound Gel that were packed in \u003Cstrong>(b)(4)\u003C\u002Fstrong>. Environmental sampling was performed by your firm on \u003Cstrong>(b)(4)\u003C\u002Fstrong> for \u003Cstrong>(b)(4)\u003C\u002Fstrong> for bottler dispense nozzle \u003Cstrong>(b)(4)\u003C\u002Fstrong> and \u003Cstrong>(b)(4)\u003C\u002Fstrong> dispensing nozzle \u003Cstrong>(b)(4)\u003C\u002Fstrong> and were recorded as out of specification for aerobic plate counts of 4,100 and 4,000 Colony Forming Units (CFUs) respectively. Your firm performed re-tests on \u003Cstrong>(b)(4)\u003C\u002Fstrong> that were in specification, but there was no documented justification for the dismissal of the initial data nor was any out of specification investigation performed. \u003C\u002Fp>\u003Cp>B. Your firm’s established worst case locations for the \u003Cstrong>(b)(4)\u003C\u002Fstrong> locations listed in Section 2.0 of this procedure are not based on testing or data such as a bioburden\u003Cstrong>(b)(4)\u003C\u002Fstrong> study. You have not adequately demonstrated that the areas chosen are the worst case in terms of number or variety of organisms.\u003C\u002Fp>\u003Cp>C. Section 2.0 of this procedure, which states “The specified test regimen will be conducted \u003Cstrong>(b)(4)\u003C\u002Fstrong> unless findings are significant, in which case, Management may direct more frequent testing” is not adequate. It fails to define what constitutes significant findings. For example, your firm’s management did not consider directing more frequent testing after September 29, 2025, when the monitoring results for the \u003Cstrong>(b)(4)\u003C\u002Fstrong> failed testing with a result of ≥25,000 CFUs.\u003C\u002Fp>\u003Cp>Your firm’s responses to 1A are not adequate. Your firm states in your responses that you will be implementing a correction to modify SOP 907-030 such that the use of environmental \u003Cstrong>(b)(4)\u003C\u002Fstrong> and air plates will only be triggered when and after the final microbial testing indicates that a lot is out of specification and will be used to trace the source of the problem. The requirements to establish environmental monitoring procedures are to ensure control of conditions, periodic inspection of control systems, and documentation and review of results. Only performing environmental \u003Cstrong>(b)(4)\u003C\u002Fstrong> and air plates testing after the final microbial testing fails is not adequate.\u003C\u002Fp>\u003Cp>Environmental control testing is crucial in non-sterile gel manufacturing to identify and prevent contamination by objectionable microorganisms, ensuring product safety, and efficacy. It validates that manufacturing environments (air, surfaces, water) are controlled to limit bioburden, preventing microbial degradation or toxins that could harm patients or damage the product's chemical properties.\u003C\u002Fp>\u003Cp>Your firm’s responses to 1B are not adequate. Your firm states the intent was to use the results of the recommended overly conservative sampling plan (worst case locations for environmental sample collection based on the opinion of consultants) and evaluate if this “test and adjust” methodology would have any effect on the finished product since its integrity and safety is assured by the final lot of microbial testing. There was no evidence provided in your responses that the areas chosen by the consultants were the worst case in terms of number or variety of organisms, and the corrective action provided in your responses of only performing environmental testing when the gel fails final lot microbial testing is not sufficient to detect all contaminants.\u003C\u002Fp>\u003Cp>Your firm’s responses to 1C is not adequate. Your firm states that “the fact that there was no change in the frequency of the testing does not indicate that the company failed to follow its own procedures or that such change would have been necessary”. The \u003Cstrong>(b)(4)\u003C\u002Fstrong> monitoring results for the \u003Cstrong>(b)(4)\u003C\u002Fstrong> had a failing result of >25,000, which is orders of magnitude above your identified acceptable level provided in your Quality Assurance Environmental Testing procedure (Number 907-030 rev. 5, section 2) for Aerobic Plate Count (APC): \u003Cstrong>(b)(4)\u003C\u002Fstrong>. Your procedure does not clearly define “significant finding” and you do not justify why this failing result is not significant. This failing result is reasonably considered as a “significant finding” that needs to be investigated where your firm needs to identify the action(s) needed to correct and prevent recurrence of quality problems in the packaging area that can lead to contaminated ultrasound gel.\u003C\u002Fp>\u003Cp>2. Failure to establish procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). Specifically, your firm failed to adequately establish a Corrective and Preventive Action (CAPA) procedure that addresses all potential quality data sources for evaluation and escalation to CAPAs as needed. Although your “Corrective and Preventive Actions” Number 908-019, Revision 003 states under section 2.0 “any NEXT Medical employee may recommend a corrective or preventive action, or one may be initiated as a result of customer feedback, internal audits, directives from a regulatory agency, risk assessments, Management Review, supplier input, trends in nonconforming material and products, or any information that reveals an adverse effect on product quality and customer service”; it does not list all data sources that your firm is evaluating to determine the need for escalation to a CAPA. As a result, your firm is not initiating CAPAs to investigate the cause of nonconformities of product processes, and other quality problems. For example:\u003C\u002Fp>\u003Cp>A. Your firm documented a consecutive increase in out of specification aerobic plate count for environmental \u003Cstrong>(b)(4)\u003C\u002Fstrong> location taken from the dispense nozzle \u003Cstrong>(b)(4)\u003C\u002Fstrong> used for packaging of nonsterile Clear Image Ultrasound Gel in \u003Cstrong>(b)(4)\u003C\u002Fstrong>. The aerobic plate counts on sample date \u003Cstrong>(b)(4)\u003C\u002Fstrong> for \u003Cstrong>(b)(4)\u003C\u002Fstrong> failed for 4,000 Colony Forming Units (CFUs). Your firm performed re-tests on \u003Cstrong>(b)(4)\u003C\u002Fstrong> that were in specification but did not recommend corrective actions for the initial failure or after September 29, 2025 when the monitoring results for the \u003Cstrong>(b)(4)\u003C\u002Fstrong> had another failing result of ≥25,000 CFUs. From the time period of August 27, 2025 to October 22, 2025, three lots (\u003Cstrong>(b)(4)\u003C\u002Fstrong>) of Clear Image Ultrasonic gel were packaged in \u003Cstrong>(b)(4)\u003C\u002Fstrong> with \u003Cstrong>(b)(4)\u003C\u002Fstrong>, totaling \u003Cstrong>(b)(4)\u003C\u002Fstrong> cases. Corrective and preventive actions were not initiated.\u003C\u002Fp>\u003Cp>B. Procedure 907-030, revision 005 titled “Quality Assurance Environmental Testing” states in section 6.1.12 to “ship via overnight to \u003Cstrong>(b)(4)\u003C\u002Fstrong> for analysis” of the \u003Cstrong>(b)(4)\u003C\u002Fstrong>. \u003Cstrong>(b)(4)\u003C\u002Fstrong> samples were collected on \u003Cstrong>(b)(4)\u003C\u002Fstrong> and were not sent to the lab until \u003Cstrong>(b)(4)\u003C\u002Fstrong>. These \u003Cstrong>(b)(4)\u003C\u002Fstrong> samples were tested on \u003Cstrong>(b)(4)\u003C\u002Fstrong> and \u003Cstrong>(b)(4)\u003C\u002Fstrong> and the bottler dispense nozzle \u003Cstrong>(b)(4)\u003C\u002Fstrong>, and the \u003Cstrong>(b)(4)\u003C\u002Fstrong> dispensing nozzle \u003Cstrong>(b)(4)\u003C\u002Fstrong> samples failed for aerobic plate counts of 4,100 and 4,000 Colony Forming Units (CFUs). Although this incident was recorded in a note to file dated \u003Cstrong>(b)(4)\u003C\u002Fstrong>, corrective and preventive actions were not initiated.\u003C\u002Fp>\u003Cp>Your firm’s responses to FDA-483 observation 2A are not adequate. Your firm states in your responses that the “out of specification results from the environmental testing did not reveal that the materials or finished product had been adversely affected or that it otherwise did not meet specifications”. Your firm has already released non-sterile ultrasound gel that did not meet specifications. Specifically, you have received complaints of unusual odor and cloudiness which you confirmed to be contaminated. In addition, your firm determined in your responses “that the provisions of Section 2 of SOP 908-019, Rev 003 were not applicable and no CAPA was required on that basis” due to an inadequate CAPA procedure. As already noted, your procedure does not adequately identify existing and potential causes of nonconformances in which to investigate, determine and implement corrective and preventive actions. Your firm failed to prevent the recurrence of the same quality issue when the aerobic plate counts on sample date \u003Cstrong>(b)(4)\u003C\u002Fstrong> for \u003Cstrong>(b)(4)\u003C\u002Fstrong> failed for 4,000 Colony Forming Units (CFUs) and then on September 29, 2025 the monitoring results for the \u003Cstrong>(b)(4)\u003C\u002Fstrong> had another failing result of ≥25,000 CFUs.\u003C\u002Fp>\u003Cp>The adequacy of your firm’s response to 2B cannot be determined at this time. Your firm plans to update procedure SOP-019 to include process nonconformities as a quality data input for the determination of CAPAs in the future. This will include failure to ship laboratory samples within the designated \u003Cstrong>(b)(4)\u003C\u002Fstrong>.\u003C\u002Fp>\u003Cp>3. Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). Specifically, your firm failed to implement “Product Development and Management of Design Changes” procedure, Number 500-004, section 7.1, which states “the process of making a significant change to an existing product involves a number of stages where information is managed in a very controlled environment consisting of inputs, outputs, verification processes and formal design reviews”. For example:\u003C\u002Fp>\u003Cp>A. Your firm introduced a new label insert (artwork \u003Cstrong>(b)(4)\u003C\u002Fstrong>, rev A) between \u003Cstrong>(b)(4)\u003C\u002Fstrong> and \u003Cstrong>(b)(4)\u003C\u002Fstrong> for your non-sterile gel that added contraindications and listed procedures requiring the use of sterile gel. Your firm characterized this as a marketing reminder processed through your label approval process rather than a design change that requires design verification or validation for the new label; \u003Cstrong>(b)(4)\u003C\u002Fstrong> batches were produced with this insert. However, this change was made as a result of a safety concern connected to the non-sterile gel contamination issue reported by the Center for Disease Control (CDC).\u003C\u002Fp>\u003Cp>B. Your firm performed a design change on your Clear Image Ultrasound Scanning Gel in which a preservative ingredient was replaced and design verification and\u002For validation was not performed. This new preservative was a major formula change from \u003Cstrong>(b)(4)\u003C\u002Fstrong> to \u003Cstrong>(b)(4)\u003C\u002Fstrong> (preservative and humectant enhancement). Your new preservative formula change adds a new specific effectiveness against paraburkholderia that was not part of the original formulation that could impact the performance, safety, and effectiveness of the ultrasound gel that would require design verification and\u002For validation before implementation.\u003C\u002Fp>\u003Cp>Your firm’s responses to 3A are not adequate. Your firm states in your response that “although we respectfully disagree with the proposition that the development of labeling materials (including advertising and promotional materials) necessarily constitute a change to a device’s specifications”. In your March 19 response, you included your revised Labels and Labeling Control procedure, SOP 703-001, and Section 2 states “All new or revised labeling shall be evaluated to determine whether the change impacts the device specifications. If the labeling change represents a modification to the device specifications, the change should be handled as a design change to the finished device.” This procedure is inadequate because it only considers a labeling change that impacts device specifications. Change control requirements apply to any change to the device, its labeling or its packaging. Additionally, your firm states in your responses that “NEXT respectfully disagrees with this observation as it appears to not be consistent with the facts as we understand them”. “The issuance of Artwork \u003Cstrong>(b)(4)\u003C\u002Fstrong>, Rev A did not constitute a change to any “purchased, in-process or finished product” and was, instead an example of reminder labeling that did not add or delete any device contraindications or otherwise affect the device’s specifications”. This response is not adequate. Your firm characterized this as a marketing reminder rather than a design change conducted in response to a safety concern and did not evaluate the need for or conduct design verification or validation for the new label, processing it only through your label approval process.\u003C\u002Fp>\u003Cp>Your firm’s responses to 3B are not adequate. We acknowledge the additional testing you’re performing of the gel to verify it still meets specifications; however, your response is inadequate in that you have not demonstrated that the “change in preservative did not affect the gel’s mechanical properties or performance specifications”. The new preservative formula is a major formula change from \u003Cstrong>(b)(4)\u003C\u002Fstrong> to \u003Cstrong>(b)(4)\u003C\u002Fstrong> which adds a new specific effectiveness against paraburkholderia that was not part of the original formulation that could impact the performance, safety, and effectiveness of the ultrasound gel that would require design verification and\u002For validation before implementation. Even though sterility may not be required, your firm must limit the number of organisms in the non-sterile Ultrasound gel throughout its shelf life.\u003C\u002Fp>\u003Cp>\u003Cstrong>\u003Cu>Corrections and Removals Violation\u003C\u002Fu>\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Our inspection also revealed that your firm’s Ultrasound Scanning Gel, distributed under the brand names Clear Image and MediChoice 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 806 – Medical Devices; Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:\u003C\u002Fp>\u003Cp>Failure to submit a Report required by 21 CFR 806.10 to FDA, within 10 working days of initiating the correction or removal. For example: your firm found and CDC confirmed that certain lots of your Clear Image and MediChoice Ultrasound Scanning Gels were contaminated with Paraburkholderia. You sent customer letters and made calls using your firm’s telephone script on 07\u002F23\u002F2025, to inform customers and offer \"free replacement\" or \"disposal directions\". CDRH’s clinical review concludes that use of the contaminated gel may present a risk to health. This action is a medical device correction or removal initiated to reduce a risk to health posed by the device or to remedy a violation of the Act caused by the device which may present a risk to health, for which you are required to submit a Report of Correction or Removal to FDA. As of 12\u002F10\u002F2025, you did not submit a Medical Device Report of Correction or Removal to FDA for this action.\u003C\u002Fp>\u003Cp>Your firm’s responses are not adequate. You have not submitted a Report of Correction or Removal to FDA as of August 13, 2026.\u003C\u002Fp>\u003Cp>\u003Cstrong>\u003Cu>Unapproved Device Violation\u003C\u002Fu>\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Our inspection also revealed that the Ultrasound Scanning Gel, distributed under the brand names Clear Image and MediChoice, is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The device is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)] The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http:\u002F\u002Fwww.fda.gov\u002FMedicalDevices\u002FDeviceRegulationandGuidance\u002FHowtoMarketYourDevice\u002Fdefault.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.\u003C\u002Fp>\u003Cp>Specifically, the Clear Image Ultrasound Scanning Gel was cleared under K883917 as a coupling agent during ultrasound procedures to eliminate air between transducer surface and skin to facilitate imaging. Your firm changed the preservative in the subject ultrasound gel formulation from \u003Cstrong>(b)(4)\u003C\u002Fstrong> to \u003Cstrong>(b)(4)\u003C\u002Fstrong> in 2024, which is considered a modification in material formulation that could significantly affect the device's safety or effectiveness. These changes thus require a 510(k) as provided in 21 CFR 807.81(a)(3)(i).\u003C\u002Fp>\u003Cp>The change could affect the device’s biocompatibility, stability, sterility and shelf life. As described here, the new preservative, \u003Cstrong>(b)(4)\u003C\u002Fstrong> (which contains \u003Cstrong>(b)(4)\u003C\u002Fstrong> and \u003Cstrong>(b)(4)\u003C\u002Fstrong>), represents a change in the chemical profile compared to \u003Cstrong>(b)(4)\u003C\u002Fstrong>, and therefore the biocompatibility must be re-evaluated. Your firm must ensure that the new preservative maintains the same preservative effectiveness, stability, sterility and shelf-life claims as previously cleared. The repeat biocompatibility testing, preservative effectiveness, shelf life, and stability should be reviewed in a new 510(k) by the Agency. The firm must demonstrate that the number of organisms in the subject ultrasound gel is limited throughout its shelf life.\u003C\u002Fp>\u003Cp>Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.\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. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.\u003C\u002Fp>\u003Cp>On February 2, 2024, the FDA issued a \u003Cu>final rule\u003C\u002Fu> 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 inspection on November 10, 2025, through December 10, 2025 was conducted pursuant to the QS Regulation, which was in effect at the time of the inspection. 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>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, as well as 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. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. 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 Establishment Assessment Team 1 Assistant Director Gina Brackett at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case 727918” when replying. If you have any questions about the contents of this letter, please contact: Robert Maffei, Compliance Officer at Robert.Maffei@fda.hhs.gov.\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\u003C\u002Fp>\u003Cp>Barbara C. Marsden\u003Cbr>Director\u003Cbr>Office of Regulatory Programs\u003Cbr>Office of Product Evaluation and Quality\u003Cbr>Center for Devices and Radiological Health\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\nRecipient Name\n\nMs. Julia M. Jacobson\n\nRecipient Title\n\nPresident and CEO\n\nNext Medical Products Company, LLC\n\n45 Columbia Road\n\nBranchburg, NJ 08876\n\nUnited States\n\n(b)(6), (b)(7)(C)\n\nIssuing Office:\n\nCenter for Devices and Radiological Health\n\nUnited States\n\nWARNING LETTER\nCMS #727918\nAugust 19, 2026\nDear Ms. Jacobson:\nDuring an inspection of your firm located in Branchburg, NJ from November 10, 2025 through December 10, 2025, an investigator from the United States Food and Drug Administration (FDA) determined that your firm manufactures Clear Image Ultrasound Gel, Clear Image Sterile, non-sterile MediChoice Ultrasound Gel, and Clear Image Singles. 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 any function of the body.\nQuality System Regulation Violations\nThis inspection revealed that these devices 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. We received responses from you dated January 2, 2026 and March 19, 2026 (responses), concerning our investigator observations noted on the Form FDA 483 (FDA 483), List of Inspectional Observations, that was issued to you on December 10, 2025. We address these responses below, in relation to each of the noted violations. These violations include, but are not limited to, the following:\n1. Failure to establish and maintain procedures where environmental conditions that could reasonably be expected to have an adverse effect on product quality, as required by 21 CFR 820.70(c). Specifically, “Quality Assurance Environmental Testing” procedure, Number 907-030, Revision 005 is not adequate in that:\nA. Section 2.0 of this procedure, which states “(b)(4) will be conducted (b)(4) on each packaging line. (b)(4)…” is not adequate. You have not demonstrated or justified why (b)(4) test result can be negated simply by (b)(4). Further, your procedure does not require investigating failed test results nor does it address documenting a justification for the dismissal of the initial failed results. For example, your firm established environmental (b)(4) locations for Lots of Clear Image Ultrasound Gel that were packed in (b)(4). Environmental sampling was performed by your firm on (b)(4) for (b)(4) for bottler dispense nozzle (b)(4) and (b)(4) dispensing nozzle (b)(4) and were recorded as out of specification for aerobic plate counts of 4,100 and 4,000 Colony Forming Units (CFUs) respectively. Your firm performed re-tests on (b)(4) that were in specification, but there was no documented justification for the dismissal of the initial data nor was any out of specification investigation performed.\nB. Your firm’s established worst case locations for the (b)(4) locations listed in Section 2.0 of this procedure are not based on testing or data such as a bioburden(b)(4) study. You have not adequately demonstrated that the areas chosen are the worst case in terms of number or variety of organisms.\nC. Section 2.0 of this procedure, which states “The specified test regimen will be conducted (b)(4) unless findings are significant, in which case, Management may direct more frequent testing” is not adequate. It fails to define what constitutes significant findings. For example, your firm’s management did not consider directing more frequent testing after September 29, 2025, when the monitoring results for the (b)(4) failed testing with a result of ≥25,000 CFUs.\nYour firm’s responses to 1A are not adequate. Your firm states in your responses that you will be implementing a correction to modify SOP 907-030 such that the use of environmental (b)(4) and air plates will only be triggered when and after the final microbial testing indicates that a lot is out of specification and will be used to trace the source of the problem. The requirements to establish environmental monitoring procedures are to ensure control of conditions, periodic inspection of control systems, and documentation and review of results. Only performing environmental (b)(4) and air plates testing after the final microbial testing fails is not adequate.\nEnvironmental control testing is crucial in non-sterile gel manufacturing to identify and prevent contamination by objectionable microorganisms, ensuring product safety, and efficacy. It validates that manufacturing environments (air, surfaces, water) are controlled to limit bioburden, preventing microbial degradation or toxins that could harm patients or damage the product's chemical properties.\nYour firm’s responses to 1B are not adequate. Your firm states the intent was to use the results of the recommended overly conservative sampling plan (worst case locations for environmental sample collection based on the opinion of consultants) and evaluate if this “test and adjust” methodology would have any effect on the finished product since its integrity and safety is assured by the final lot of microbial testing. There was no evidence provided in your responses that the areas chosen by the consultants were the worst case in terms of number or variety of organisms, and the corrective action provided in your responses of only performing environmental testing when the gel fails final lot microbial testing is not sufficient to detect all contaminants.\nYour firm’s responses to 1C is not adequate. Your firm states that “the fact that there was no change in the frequency of the testing does not indicate that the company failed to follow its own procedures or that such change would have been necessary”. The (b)(4) monitoring results for the (b)(4) had a failing result of >25,000, which is orders of magnitude above your identified acceptable level provided in your Quality Assurance Environmental Testing procedure (Number 907-030 rev. 5, section 2) for Aerobic Plate Count (APC): (b)(4). Your procedure does not clearly define “significant finding” and you do not justify why this failing result is not significant. This failing result is reasonably considered as a “significant finding” that needs to be investigated where your firm needs to identify the action(s) needed to correct and prevent recurrence of quality problems in the packaging area that can lead to contaminated ultrasound gel.\n2. Failure to establish procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a). Specifically, your firm failed to adequately establish a Corrective and Preventive Action (CAPA) procedure that addresses all potential quality data sources for evaluation and escalation to CAPAs as needed. Although your “Corrective and Preventive Actions” Number 908-019, Revision 003 states under section 2.0 “any NEXT Medical employee may recommend a corrective or preventive action, or one may be initiated as a result of customer feedback, internal audits, directives from a regulatory agency, risk assessments, Management Review, supplier input, trends in nonconforming material and products, or any information that reveals an adverse effect on product quality and customer service”; it does not list all data sources that your firm is evaluating to determine the need for escalation to a CAPA. As a result, your firm is not initiating CAPAs to investigate the cause of nonconformities of product processes, and other quality problems. For example:\nA. Your firm documented a consecutive increase in out of specification aerobic plate count for environmental (b)(4) location taken from the dispense nozzle (b)(4) used for packaging of nonsterile Clear Image Ultrasound Gel in (b)(4). The aerobic plate counts on sample date (b)(4) for (b)(4) failed for 4,000 Colony Forming Units (CFUs). Your firm performed re-tests on (b)(4) that were in specification but did not recommend corrective actions for the initial failure or after September 29, 2025 when the monitoring results for the (b)(4) had another failing result of ≥25,000 CFUs. From the time period of August 27, 2025 to October 22, 2025, three lots ((b)(4)) of Clear Image Ultrasonic gel were packaged in (b)(4) with (b)(4), totaling (b)(4) cases. Corrective and preventive actions were not initiated.\nB. Procedure 907-030, revision 005 titled “Quality Assurance Environmental Testing” states in section 6.1.12 to “ship via overnight to (b)(4) for analysis” of the (b)(4). (b)(4) samples were collected on (b)(4) and were not sent to the lab until (b)(4). These (b)(4) samples were tested on (b)(4) and (b)(4) and the bottler dispense nozzle (b)(4), and the (b)(4) dispensing nozzle (b)(4) samples failed for aerobic plate counts of 4,100 and 4,000 Colony Forming Units (CFUs). Although this incident was recorded in a note to file dated (b)(4), corrective and preventive actions were not initiated.\nYour firm’s responses to FDA-483 observation 2A are not adequate. Your firm states in your responses that the “out of specification results from the environmental testing did not reveal that the materials or finished product had been adversely affected or that it otherwise did not meet specifications”. Your firm has already released non-sterile ultrasound gel that did not meet specifications. Specifically, you have received complaints of unusual odor and cloudiness which you confirmed to be contaminated. In addition, your firm determined in your responses “that the provisions of Section 2 of SOP 908-019, Rev 003 were not applicable and no CAPA was required on that basis” due to an inadequate CAPA procedure. As already noted, your procedure does not adequately identify existing and potential causes of nonconformances in which to investigate, determine and implement corrective and preventive actions. Your firm failed to prevent the recurrence of the same quality issue when the aerobic plate counts on sample date (b)(4) for (b)(4) failed for 4,000 Colony Forming Units (CFUs) and then on September 29, 2025 the monitoring results for the (b)(4) had another failing result of ≥25,000 CFUs.\nThe adequacy of your firm’s response to 2B cannot be determined at this time. Your firm plans to update procedure SOP-019 to include process nonconformities as a quality data input for the determination of CAPAs in the future. This will include failure to ship laboratory samples within the designated (b)(4).\n3. Failure to establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation, as required by 21 CFR 820.30(i). Specifically, your firm failed to implement “Product Development and Management of Design Changes” procedure, Number 500-004, section 7.1, which states “the process of making a significant change to an existing product involves a number of stages where information is managed in a very controlled environment consisting of inputs, outputs, verification processes and formal design reviews”. For example:\nA. Your firm introduced a new label insert (artwork (b)(4), rev A) between (b)(4) and (b)(4) for your non-sterile gel that added contraindications and listed procedures requiring the use of sterile gel. Your firm characterized this as a marketing reminder processed through your label approval process rather than a design change that requires design verification or validation for the new label; (b)(4) batches were produced with this insert. However, this change was made as a result of a safety concern connected to the non-sterile gel contamination issue reported by the Center for Disease Control (CDC).\nB. Your firm performed a design change on your Clear Image Ultrasound Scanning Gel in which a preservative ingredient was replaced and design verification and\u002For validation was not performed. This new preservative was a major formula change from (b)(4) to (b)(4) (preservative and humectant enhancement). Your new preservative formula change adds a new specific effectiveness against paraburkholderia that was not part of the original formulation that could impact the performance, safety, and effectiveness of the ultrasound gel that would require design verification and\u002For validation before implementation.\nYour firm’s responses to 3A are not adequate. Your firm states in your response that “although we respectfully disagree with the proposition that the development of labeling materials (including advertising and promotional materials) necessarily constitute a change to a device’s specifications”. In your March 19 response, you included your revised Labels and Labeling Control procedure, SOP 703-001, and Section 2 states “All new or revised labeling shall be evaluated to determine whether the change impacts the device specifications. If the labeling change represents a modification to the device specifications, the change should be handled as a design change to the finished device.” This procedure is inadequate because it only considers a labeling change that impacts device specifications. Change control requirements apply to any change to the device, its labeling or its packaging. Additionally, your firm states in your responses that “NEXT respectfully disagrees with this observation as it appears to not be consistent with the facts as we understand them”. “The issuance of Artwork (b)(4), Rev A did not constitute a change to any “purchased, in-process or finished product” and was, instead an example of reminder labeling that did not add or delete any device contraindications or otherwise affect the device’s specifications”. This response is not adequate. Your firm characterized this as a marketing reminder rather than a design change conducted in response to a safety concern and did not evaluate the need for or conduct design verification or validation for the new label, processing it only through your label approval process.\nYour firm’s responses to 3B are not adequate. We acknowledge the additional testing you’re performing of the gel to verify it still meets specifications; however, your response is inadequate in that you have not demonstrated that the “change in preservative did not affect the gel’s mechanical properties or performance specifications”. The new preservative formula is a major formula change from (b)(4) to (b)(4) which adds a new specific effectiveness against paraburkholderia that was not part of the original formulation that could impact the performance, safety, and effectiveness of the ultrasound gel that would require design verification and\u002For validation before implementation. Even though sterility may not be required, your firm must limit the number of organisms in the non-sterile Ultrasound gel throughout its shelf life.\nCorrections and Removals Violation\nOur inspection also revealed that your firm’s Ultrasound Scanning Gel, distributed under the brand names Clear Image and MediChoice 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 806 – Medical Devices; Reports of Corrections and Removals. Significant violations include, but are not limited to, the following:\nFailure to submit a Report required by 21 CFR 806.10 to FDA, within 10 working days of initiating the correction or removal. For example: your firm found and CDC confirmed that certain lots of your Clear Image and MediChoice Ultrasound Scanning Gels were contaminated with Paraburkholderia. You sent customer letters and made calls using your firm’s telephone script on 07\u002F23\u002F2025, to inform customers and offer \"free replacement\" or \"disposal directions\". CDRH’s clinical review concludes that use of the contaminated gel may present a risk to health. This action is a medical device correction or removal initiated to reduce a risk to health posed by the device or to remedy a violation of the Act caused by the device which may present a risk to health, for which you are required to submit a Report of Correction or Removal to FDA. As of 12\u002F10\u002F2025, you did not submit a Medical Device Report of Correction or Removal to FDA for this action.\nYour firm’s responses are not adequate. You have not submitted a Report of Correction or Removal to FDA as of August 13, 2026.\nUnapproved Device Violation\nOur inspection also revealed that the Ultrasound Scanning Gel, distributed under the brand names Clear Image and MediChoice, is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption under section 520(g) of the Act, 21 U.S.C. § 360j(g). The device is also misbranded under section 502(o) of the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act, 21 U.S.C. § 360(k). For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)] The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http:\u002F\u002Fwww.fda.gov\u002FMedicalDevices\u002FDeviceRegulationandGuidance\u002FHowtoMarketYourDevice\u002Fdefault.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.\nSpecifically, the Clear Image Ultrasound Scanning Gel was cleared under K883917 as a coupling agent during ultrasound procedures to eliminate air between transducer surface and skin to facilitate imaging. Your firm changed the preservative in the subject ultrasound gel formulation from (b)(4) to (b)(4) in 2024, which is considered a modification in material formulation that could significantly affect the device's safety or effectiveness. These changes thus require a 510(k) as provided in 21 CFR 807.81(a)(3)(i).\nThe change could affect the device’s biocompatibility, stability, sterility and shelf life. As described here, the new preservative, (b)(4) (which contains (b)(4) and (b)(4)), represents a change in the chemical profile compared to (b)(4), and therefore the biocompatibility must be re-evaluated. Your firm must ensure that the new preservative maintains the same preservative effectiveness, stability, sterility and shelf-life claims as previously cleared. The repeat biocompatibility testing, preservative effectiveness, shelf life, and stability should be reviewed in a new 510(k) by the Agency. The firm must demonstrate that the number of organisms in the subject ultrasound gel is limited throughout its shelf life.\nYour firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure, injunction, and civil money penalties.\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. Should FDA determine that your devices or facilities do not meet the requirements of the Act, requests for Certificates to Foreign Governments (CFG) may not be granted.\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 inspection on November 10, 2025, through December 10, 2025 was conducted pursuant to the QS Regulation, which was in effect at the time of the inspection. 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.\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, as well as 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. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. 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 Establishment Assessment Team 1 Assistant Director Gina Brackett at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case 727918” when replying. If you have any questions about the contents of this letter, please contact: Robert Maffei, Compliance Officer at Robert.Maffei@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\nBarbara C. Marsden\nDirector\nOffice of Regulatory Programs\nOffice of Product Evaluation and Quality\nCenter for Devices and Radiological Health","2026-11-10T01:03:13.668+00:00",[23,24,25,9,10,26,26,26],"\u003Ctime datetime=\"2026-11-03T05:00:00Z\">11\u002F03\u002F2026\u003C\u002Ftime>\n","\u003Ctime datetime=\"2026-08-19T04:00:00Z\">08\u002F19\u002F2026\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fnext-medical-products-company-llc-727918-08192026\">Next Medical Products Company, LLC\u003C\u002Fa>","","2026-11-10T01:02:16.121874+00:00","2026-11-10T01:03:14.149705+00:00",{"510k":30,"classification":31,"enforcement":32,"event":33,"event_backfill":34,"pma":35,"warning_letter":36},"2026-11-09T02:00:35.105+00:00","2026-11-09T02:00:29.052+00:00","2026-11-09T02:00:32.696+00:00","2026-11-12T04:02:32.647+00:00","2026-09-07T05:17:28.839+00:00","2026-11-09T02:00:36.308+00:00","2026-11-10T01:03:48.189+00:00"]