[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-fresenius-medical-care-ag-co-kgaa-730319-08252026":3,"fda-latest-sync-dates":30},{"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":15,"marcs_cms_no":16,"product_type":17,"delivery_method":18,"recipient_name":19,"recipient_title":8,"body_html":20,"body_text":21,"body_fetched_at":22,"medical_device_id":8,"raw":23,"created_at":28,"updated_at":29},21643,"fresenius-medical-care-ag-co-kgaa-730319-08252026","Warning Letter","Fresenius Medical Care AG & Co. KGaA",null,"Center for Drug Evaluation and Research (CDER)","CGMP\u002FFinished Pharmaceuticals\u002FAdulterated","2026-09-01","2026-08-25","Issued","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Ffresenius-medical-care-ag-co-kgaa-730319-08252026","320-26-119","730319","Drugs","Via Email Return Receipt Requested","Ms. Helen Giza","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n  \u003Chr>\n \n\n\u003Cdiv class=\"inset-column\">\n  \u003Cdl class=\"lcds-description-list--grid\">\n\n              \u003Cdt class=\"cell-1_1\">Delivery Method:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_1\">Via Email Return Receipt Requested\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n              \u003Cdt class=\"cell-1_2\">Reference #:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_2\">320-26-119\u003C\u002Fdd>\n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Drugs                          \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 class=\"row inset-column\">\n  \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-name field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Name\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Ms. Helen Giza\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                                \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-title field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Title\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Chief Executive Officer \u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>Fresenius Medical Care AG & Co. KGaA\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">Else-Kröner-Straße 1\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"postal-code\">61352\u003C\u002Fspan> \u003Cspan class=\"locality\">Bad Homburg v.d. Höhe\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">Germany\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n            \n            \u003Cdd>\u003C!-- Loop this field. For FDA Office content type. Display the Other contact channel is a dd span with an icon-->\n\n    \u003C\u002Fdd>\u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:(b)(4)\"> (b)(4)\u003C\u002Fa>\u003C\u002Fdd>\n\n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n          \n          \u003Cdt>Issuing Office:\u003C\u002Fdt>\n        \n         \n          \u003Cdd>Center for Drug Evaluation and Research (CDER)\u003C\u002Fdd>\n        \n         \n          \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n        \n        \n        \n        \n        \n    \u003C\u002Fdl>\n    \u003Cdl class=\"\"> \n      \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>Warning Letter\u003C\u002Fstrong> 320-26-119\u003C\u002Fp>\u003Cp>August 25, 2026\u003C\u002Fp>\u003Cp>Dear Ms. Giza:\u003C\u002Fp>\u003Cp>The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Fresenius USA Manufacturing, Inc. dba Fresenius Medical Care North America Ogden Plant, FEI 1713747, at 475 W. 13th St., Ogden, Utah, from March 2 to 6, 2026.\u003C\u002Fp>\u003Cp>This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).\u003C\u002Fp>\u003Cp>Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).\u003C\u002Fp>\u003Cp>We reviewed your March 27, 2026, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.\u003C\u002Fp>\u003Cp>During our inspection, our investigator observed specific violations including, but not limited to, the following.\u003C\u002Fp>\u003Cp>\u003Cstrong>1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>You failed to adequately investigate customer complaints for the large volume parenteral (LVP) bag drug products you manufacture. Your investigations were not thorough and did not appropriately evaluate the risk to product quality. You also failed to identify and implement adequate and timely corrective actions and preventive actions (CAPAs).\u003C\u002Fp>\u003Cp>Specifically, in August 2025 you initiated an investigation due to a complaint trend for leaking bags of Delflex Peritoneal Dialysis Solution. This investigation noted that you eventually received 35 complaints covering approximately 156 bags from multiple batches. Your investigation attributed the bag leaks “to holes caused by printing.”\u003C\u002Fp>\u003Cp>Despite your Risk Management Matrix indicating peritonitis as a potential harm and recommending the highest severity level, you instead assigned the lowest severity level with the potential harm being “damage of property.” Although you ultimately conducted a recall in April 2026 after our inspection, you chose not to conduct a recall following the results of your August 2025 investigation.\u003C\u002Fp>\u003Cp>Your justifications for these decisions included: the lack of attributable peritonitis cases, product labeling instructed users to inspect bags for leaks, the leaks should be readily detected before treatment, and leaking fluid should collect in the overwrap.\u003C\u002Fp>\u003Cp>Notably, following our inspection, you state that you reexamined part of one batch and “found presence of perforations in the primary container without substantial fluid present in the overwrap,” demonstrating your error in assuming that users can consistently detect leaks. Moreover, users should not be relied upon to detect leaking bags. In addition, once you knew of the trend of leaking bags in marketed product, there should have been a commensurate increase in urgency to contain the issue.\u003C\u002Fp>\u003Cp>Your decision not to recall these batches at that time exposed peritoneal dialysis (PD) patients to potentially non-sterile drug products. The use of non-sterile PD solution elevates the risk of developing peritonitis, the clinical consequences of which may include serious and potentially life-threatening complications. In addition, a significant component in this drug, dextrose, could serve as a nutritional source for contaminating microorganisms and promote their growth.\u003C\u002Fp>\u003Cp>In your response, you acknowledge that the risk assessment should have been based on peritonitis risk, and you should not have assumed that users would detect any leaking unit. Your firm reassessed the risk for this incident and decided to recall the impacted lots. You also revised your procedure to assure that known and potential harms are evaluated during risk assessments.\u003C\u002Fp>\u003Cp>Your response is inadequate. It does not include a sufficient CAPA, including improving detection of leaking units during manufacturing to prevent their release and distribution. This is especially concerning considering the numerous complaints, Field Alert Reports, and recalled batches in the last three years for leaking LVP bags manufactured at your facility. Notably, two Field Alert Reports you previously submitted involved leaking LVP bags with microbial contamination.\u003C\u002Fp>\u003Cp>In response to this letter, provide:\u003C\u002Fp>\u003Cul>\u003Cli>A comprehensive, independent assessment of the root causes of leaking bags including, but not limited to:\u003Cbr>o A failure mode analysis for the potential causes of leaking bags that addresses the deficiencies in the printing technology used by your firm, as well as any other potential causes associated with handling of bags by equipment and personnel\u003Cbr>o An independent review of your printing controls and their capabilities, including potential for contributing to leaking bags\u003Cbr>o An analysis of alternative printing technologies that can minimize or eliminate the printing step as a cause of leaking bags\u003Cbr>o CAPA to address the identified root causes of leaking bags, such as the replacement of the current printing technology\u003C\u002Fli>\u003Cli>A comprehensive assessment and remediation plan to ensure your quality unit (QU) is given the authority and resources to effectively function. The assessment should also include, but not be limited to:\u003Cbr>o A determination of whether procedures used by your firm are robust and appropriate\u003Cbr>o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices\u003Cbr>o A complete and final review of each batch and its related information before the QU disposition decision\u003Cbr>o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products\u003C\u002Fli>\u003Cli>A comprehensive assessment of your overall system for investigating deviations, discrepancies, complaints, out-of-specification results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, quality unit oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.\u003C\u002Fli>\u003Cli>An independent review of in-process criteria for major and critical defects, including but not limited to leakers. Perform a retrospective evaluation, including:\u003Cbr>o A list of the number and types of all defects\u003Cbr>o Detailed long-term summaries (i.e., at least 5 years) of batch performance that address the period of recurring leaking incidents\u003Cbr>o All instances of batches with atypically high defects rates, with potential root cause of these deviations\u003C\u002Fli>\u003Cli>Provide a comprehensive process capability assessment of your manufacturing process, with special emphasis on the capability of critical operational steps including but not limited to the detection of leaking bags, and any related CAPA to be initiated in response to the capability assessment. Also, include an assessment of operator handling practices and machine stresses that could lead to loss of bag integrity.\u003C\u002Fli>\u003Cli>Provide a remediated program that provides for ongoing statistical assessment of processing line performance to vigilantly monitor state of control. Specifically, include your program for statistical process control of each batch of drug products manufactured by your firm to monitor intra-batch and inter-batch variation and promptly detect a drift in process control.\u003C\u002Fli>\u003Cli>Provide the protocol for and subsequent report from an independent review of the qualification report(s), validation report(s), and maintenance program for the equipment that forms, fills, and seals your drug product bags. Also include an independent review of the methods used to detect leaking bags throughout processing, the frequency of monitoring, and the validation report for each method.\u003C\u002Fli>\u003Cli>A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program for process performance qualification, and ongoing vigilant monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control. Also, describe your equipment and facility qualification program.\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cstrong>2. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Your visual inspection program was inadequate to ensure that sterile injectable drug products were essentially free of visible particulates. Specifically, you failed to appropriately qualify personnel who performed visual inspections of injectable products. Your visual inspection qualification kit did not include adequately representative visible particulates (e.g., size), and your qualification records lacked sufficient detail to determine the qualifications of staff who perform visual inspection of \u003Cstrong>(b)(4)\u003C\u002Fstrong> bags.\u003C\u002Fp>\u003Cp>Your response states that your visual inspection qualification kit contained representative particulates. You add that you are developing a new kit that will continue to contain such particles, and that you will periodically review production and post market data to verify the kit remains representative.\u003C\u002Fp>\u003Cp>Your response is inadequate. It does not address the failure of your visual inspection qualification program to demonstrate that visual inspection personnel can detect visible particles at a level that meets the appropriate standard. The example particles in your kit may not be representative of smaller particles in your drug products.\u003C\u002Fp>\u003Cp>Visual detection of particulates is a probabilistic process that depends on, among other things, ensuring that visible particulates can be reproducibly detected by trained personnel with appropriate visual acuity. Your qualification kit should contain particles of a size and composition that adequately challenge inspectors across the range of particulate sizes that may be present in your drug product and should be qualified to demonstrate that inspectors can reliably detect visible particulates relevant to your specific product and container\u002Fclosure system. These qualification kits should typically contain particles in the range of 100-150 microns to adequately challenge inspector detection capabilities.\u003C\u002Fp>\u003Cp>In response to this letter, provide:\u003C\u002Fp>\u003Cul>\u003Cli>A remediation plan that better assures ongoing management oversight throughout the manufacturing lifecycle of all drug products. Provide a more data-driven and scientifically sound program that identifies sources of process variability, and assures that manufacturing operations meet appropriate parameters and quality standards. This includes, but is not limited to, evaluating suitability of equipment for its intended use, ensuring quality of input materials, determining the capability and reliability of each manufacturing process step and its controls, and vigilant ongoing monitoring of process performance and product quality.\u003C\u002Fli>\u003Cli>A comprehensive, independent assessment and remediation plan for your visual inspection program to ensure compliance with CGMP. The remediation plan should include but not be limited to:\u003Cbr>o Improved visual inspection methods, as appropriate\u003Cbr>o Improved qualification protocols and associated records for all staff performing visual inspection\u003Cbr>o Incorporation of U.S. Pharmacopeia (USP) <790> Visible Particulates in Injections standards into your procedures\u003Cbr>o Use of an appropriate range of visible particulate types and sizes, including particles of also approximately 100-150 microns, as part of staff qualification studies\u003Cbr>o All other provisions necessary to ensure appropriate qualification of visual particulate inspectors\u003C\u002Fli>\u003C\u002Ful>\u003Cp>\u003Cstrong>Drug Recall\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>On April 6, 2026, you issued voluntary recalls of DELFLEX Dextrose Peritoneal Dialysis Solution due to Lack of Assurance of Sterility. The company announcements were posted to the FDA website:\u003Cbr>https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fires\u002Findex.cfm?Product=219904\u003Cbr>https:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fires\u002Findex.cfm?Product=219905\u003C\u002Fp>\u003Cp>\u003Cstrong>CGMP Consultant\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit\u003Cem>\u003Cstrong>\u003Csup>1\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem> of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.\u003C\u002Fp>\u003Cp>\u003Cstrong>Conclusion\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.\u003C\u002Fp>\u003Cp>If you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug\u003C\u002Fp>\u003Cp>Shortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356C(b). This also allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.\u003C\u002Fp>\u003Cp>Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.\u003C\u002Fp>\u003Cp>Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.\u003C\u002Fp>\u003Cp>This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days\u003Cem>\u003Cstrong>\u003Csup>1\u003C\u002Fsup>\u003C\u002Fstrong>\u003C\u002Fem>. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.\u003C\u002Fp>\u003Cp>Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 1713747 and ATTN: Russell Riley.\u003C\u002Fp>\u003Cp>Sincerely,\u003Cbr>\u002FS\u002F\u003C\u002Fp>\u003Cp>Francis Godwin\u003Cbr>Director\u003Cbr>Office of Manufacturing Quality\u003Cbr>Office of Compliance\u003Cbr>Center for Drug Evaluation and Research\u003C\u002Fp>\u003Cp>CC: Mr. Brett A. Barton\u003Cbr>General Manager\u003Cbr>Vice President of Manufacturing Operations Ogden Plant\u003Cbr>Fresenius USA Manufacturing, Inc. dba Fresenius Medical Care North America Ogden Plant\u003Cbr>Email: \u003Cstrong>(b)(4)\u003C\u002Fstrong>\u003C\u002Fp>\u003Cp>________________________\u003C\u002Fp>\u003Cp>\u003Cem>\u003Cstrong>1\u003C\u002Fstrong>\u003C\u002Fem> Under program enhancements for the Generic Drug User Fee Amendments (GDUFA) reauthorization for fiscal years (FYs) 2023-2027, also known as the GDUFA III Commitment Letter, your facility may be eligible for a Post-Warning Letter Meeting to obtain preliminary feedback from FDA on the adequacy and completeness of your corrective action plans.\u003C\u002Fp>\n\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\n\n\n              \n                                            \n              \n            ","Delivery Method:\n\nVia Email Return Receipt Requested\n\nReference #:\n\n320-26-119\n\nProduct:\n\nDrugs\n\nRecipient:\n\nRecipient Name\n\nMs. Helen Giza\n\nRecipient Title\n\nChief Executive Officer\n\nFresenius Medical Care AG & Co. KGaA\n\nElse-Kröner-Straße 1\n\n61352 Bad Homburg v.d. Höhe\n\nGermany\n\n(b)(4)\n\nIssuing Office:\n\nCenter for Drug Evaluation and Research (CDER)\n\nUnited States\n\nWarning Letter 320-26-119\nAugust 25, 2026\nDear Ms. Giza:\nThe United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Fresenius USA Manufacturing, Inc. dba Fresenius Medical Care North America Ogden Plant, FEI 1713747, at 475 W. 13th St., Ogden, Utah, from March 2 to 6, 2026.\nThis warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).\nBecause your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).\nWe reviewed your March 27, 2026, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.\nDuring our inspection, our investigator observed specific violations including, but not limited to, the following.\n1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).\nYou failed to adequately investigate customer complaints for the large volume parenteral (LVP) bag drug products you manufacture. Your investigations were not thorough and did not appropriately evaluate the risk to product quality. You also failed to identify and implement adequate and timely corrective actions and preventive actions (CAPAs).\nSpecifically, in August 2025 you initiated an investigation due to a complaint trend for leaking bags of Delflex Peritoneal Dialysis Solution. This investigation noted that you eventually received 35 complaints covering approximately 156 bags from multiple batches. Your investigation attributed the bag leaks “to holes caused by printing.”\nDespite your Risk Management Matrix indicating peritonitis as a potential harm and recommending the highest severity level, you instead assigned the lowest severity level with the potential harm being “damage of property.” Although you ultimately conducted a recall in April 2026 after our inspection, you chose not to conduct a recall following the results of your August 2025 investigation.\nYour justifications for these decisions included: the lack of attributable peritonitis cases, product labeling instructed users to inspect bags for leaks, the leaks should be readily detected before treatment, and leaking fluid should collect in the overwrap.\nNotably, following our inspection, you state that you reexamined part of one batch and “found presence of perforations in the primary container without substantial fluid present in the overwrap,” demonstrating your error in assuming that users can consistently detect leaks. Moreover, users should not be relied upon to detect leaking bags. In addition, once you knew of the trend of leaking bags in marketed product, there should have been a commensurate increase in urgency to contain the issue.\nYour decision not to recall these batches at that time exposed peritoneal dialysis (PD) patients to potentially non-sterile drug products. The use of non-sterile PD solution elevates the risk of developing peritonitis, the clinical consequences of which may include serious and potentially life-threatening complications. In addition, a significant component in this drug, dextrose, could serve as a nutritional source for contaminating microorganisms and promote their growth.\nIn your response, you acknowledge that the risk assessment should have been based on peritonitis risk, and you should not have assumed that users would detect any leaking unit. Your firm reassessed the risk for this incident and decided to recall the impacted lots. You also revised your procedure to assure that known and potential harms are evaluated during risk assessments.\nYour response is inadequate. It does not include a sufficient CAPA, including improving detection of leaking units during manufacturing to prevent their release and distribution. This is especially concerning considering the numerous complaints, Field Alert Reports, and recalled batches in the last three years for leaking LVP bags manufactured at your facility. Notably, two Field Alert Reports you previously submitted involved leaking LVP bags with microbial contamination.\nIn response to this letter, provide:\nA comprehensive, independent assessment of the root causes of leaking bags including, but not limited to:\no A failure mode analysis for the potential causes of leaking bags that addresses the deficiencies in the printing technology used by your firm, as well as any other potential causes associated with handling of bags by equipment and personnel\no An independent review of your printing controls and their capabilities, including potential for contributing to leaking bags\no An analysis of alternative printing technologies that can minimize or eliminate the printing step as a cause of leaking bags\no CAPA to address the identified root causes of leaking bags, such as the replacement of the current printing technology\nA comprehensive assessment and remediation plan to ensure your quality unit (QU) is given the authority and resources to effectively function. The assessment should also include, but not be limited to:\no A determination of whether procedures used by your firm are robust and appropriate\no Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices\no A complete and final review of each batch and its related information before the QU disposition decision\no Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products\nA comprehensive assessment of your overall system for investigating deviations, discrepancies, complaints, out-of-specification results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, quality unit oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.\nAn independent review of in-process criteria for major and critical defects, including but not limited to leakers. Perform a retrospective evaluation, including:\no A list of the number and types of all defects\no Detailed long-term summaries (i.e., at least 5 years) of batch performance that address the period of recurring leaking incidents\no All instances of batches with atypically high defects rates, with potential root cause of these deviations\nProvide a comprehensive process capability assessment of your manufacturing process, with special emphasis on the capability of critical operational steps including but not limited to the detection of leaking bags, and any related CAPA to be initiated in response to the capability assessment. Also, include an assessment of operator handling practices and machine stresses that could lead to loss of bag integrity.\nProvide a remediated program that provides for ongoing statistical assessment of processing line performance to vigilantly monitor state of control. Specifically, include your program for statistical process control of each batch of drug products manufactured by your firm to monitor intra-batch and inter-batch variation and promptly detect a drift in process control.\nProvide the protocol for and subsequent report from an independent review of the qualification report(s), validation report(s), and maintenance program for the equipment that forms, fills, and seals your drug product bags. Also include an independent review of the methods used to detect leaking bags throughout processing, the frequency of monitoring, and the validation report for each method.\nA detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program for process performance qualification, and ongoing vigilant monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control. Also, describe your equipment and facility qualification program.\n2. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).\nYour visual inspection program was inadequate to ensure that sterile injectable drug products were essentially free of visible particulates. Specifically, you failed to appropriately qualify personnel who performed visual inspections of injectable products. Your visual inspection qualification kit did not include adequately representative visible particulates (e.g., size), and your qualification records lacked sufficient detail to determine the qualifications of staff who perform visual inspection of (b)(4) bags.\nYour response states that your visual inspection qualification kit contained representative particulates. You add that you are developing a new kit that will continue to contain such particles, and that you will periodically review production and post market data to verify the kit remains representative.\nYour response is inadequate. It does not address the failure of your visual inspection qualification program to demonstrate that visual inspection personnel can detect visible particles at a level that meets the appropriate standard. The example particles in your kit may not be representative of smaller particles in your drug products.\nVisual detection of particulates is a probabilistic process that depends on, among other things, ensuring that visible particulates can be reproducibly detected by trained personnel with appropriate visual acuity. Your qualification kit should contain particles of a size and composition that adequately challenge inspectors across the range of particulate sizes that may be present in your drug product and should be qualified to demonstrate that inspectors can reliably detect visible particulates relevant to your specific product and container\u002Fclosure system. These qualification kits should typically contain particles in the range of 100-150 microns to adequately challenge inspector detection capabilities.\nIn response to this letter, provide:\nA remediation plan that better assures ongoing management oversight throughout the manufacturing lifecycle of all drug products. Provide a more data-driven and scientifically sound program that identifies sources of process variability, and assures that manufacturing operations meet appropriate parameters and quality standards. This includes, but is not limited to, evaluating suitability of equipment for its intended use, ensuring quality of input materials, determining the capability and reliability of each manufacturing process step and its controls, and vigilant ongoing monitoring of process performance and product quality.\nA comprehensive, independent assessment and remediation plan for your visual inspection program to ensure compliance with CGMP. The remediation plan should include but not be limited to:\no Improved visual inspection methods, as appropriate\no Improved qualification protocols and associated records for all staff performing visual inspection\no Incorporation of U.S. Pharmacopeia (USP) \u003C790> Visible Particulates in Injections standards into your procedures\no Use of an appropriate range of visible particulate types and sizes, including particles of also approximately 100-150 microns, as part of staff qualification studies\no All other provisions necessary to ensure appropriate qualification of visual particulate inspectors\nDrug Recall\nOn April 6, 2026, you issued voluntary recalls of DELFLEX Dextrose Peritoneal Dialysis Solution due to Lack of Assurance of Sterility. The company announcements were posted to the FDA website:\nhttps:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fires\u002Findex.cfm?Product=219904\nhttps:\u002F\u002Fwww.accessdata.fda.gov\u002Fscripts\u002Fires\u002Findex.cfm?Product=219905\nCGMP Consultant\nBased upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit1 of your entire operation for CGMP compliance and evaluate the completion and efficacy of your corrective actions and preventive actions before you pursue resolution of your firm’s compliance status with FDA.\nConclusion\nThe violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.\nIf you are considering an action that is likely to lead to a disruption in the supply of drugs produced at your facility, FDA requests that you contact CDER’s Drug Shortages Staff immediately, at drugshortages@fda.hhs.gov, so that FDA can work with you on the most effective way to bring your operations into compliance with the law. Contacting the Drug\nShortages Staff also allows you to meet any obligations you may have to report discontinuances or interruptions in your drug manufacture under 21 U.S.C. 356C(b). This also allows FDA to consider, as soon as possible, what actions, if any, may be needed to avoid shortages and protect the health of patients who depend on your products.\nCorrect any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations may also prevent other Federal agencies from awarding contracts.\nFailure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.\nThis letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days1. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.\nSend your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 1713747 and ATTN: Russell Riley.\nSincerely,\n\u002FS\u002F\nFrancis Godwin\nDirector\nOffice of Manufacturing Quality\nOffice of Compliance\nCenter for Drug Evaluation and Research\nCC: Mr. Brett A. Barton\nGeneral Manager\nVice President of Manufacturing Operations Ogden Plant\nFresenius USA Manufacturing, Inc. dba Fresenius Medical Care North America Ogden Plant\nEmail: (b)(4)\n________________________\n1 Under program enhancements for the Generic Drug User Fee Amendments (GDUFA) reauthorization for fiscal years (FYs) 2023-2027, also known as the GDUFA III Commitment Letter, your facility may be eligible for a Post-Warning Letter Meeting to obtain preliminary feedback from FDA on the adequacy and completeness of your corrective action plans.","2026-09-07T05:14:22.608+00:00",[24,25,26,9,10,27,27,27],"\u003Ctime datetime=\"2026-09-01T04:00:00Z\">09\u002F01\u002F2026\u003C\u002Ftime>\n","\u003Ctime datetime=\"2026-08-25T04:00:00Z\">08\u002F25\u002F2026\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Ffresenius-medical-care-ag-co-kgaa-730319-08252026\">Fresenius Medical Care AG & Co. KGaA\u003C\u002Fa>","","2026-09-07T05:14:13.57002+00:00","2026-09-07T05:14:22.65811+00:00",{"510k":31,"classification":32,"enforcement":33,"event":34,"event_backfill":35,"pma":36,"warning_letter":37},"2026-09-07T05:11:19.067+00:00","2026-09-07T05:11:15.53+00:00","2026-09-07T05:11:16.99+00:00","2026-09-07T05:18:11.694+00:00","2026-09-07T05:17:28.839+00:00","2026-09-07T05:11:20.665+00:00","2026-09-07T05:15:19.69+00:00"]