Sterility Assurance

FDA Warning Letter: Baxter cited for cross-contamination and aseptic control failures

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FDA states that its March 23–April 2, 2026, inspection of Baxter Healthcare Corporation’s Round Lake drug facility found significant CGMP violations in sterile injectable manufacturing. The facility did not achieve complete separation between cephalosporin and other drug production: environmental monitoring repeatedly detected cephalosporin outside the beta-lactam area, while sampling locations, swab recovery qualification, sample timing, and finished-product sampling were inadequate. Multiple failing environmental samples were mistakenly discarded. FDA also identified deficient aseptic controls, including recurring biological indicator growth accepted during requalification, insufficiently representative media fills, inadequate ISO 5 environmental monitoring, incomplete airflow visualization studies, and turbulent non-unidirectional airflow around processing equipment. Manual visual inspection was unreliable because operator qualification, challenge particles, and inspection speed were inadequate; particulate complaints included confirmed cardboard contamination. Investigations into rising container-closure leaks and a 2025 cefazolin sterility failure were also inadequate, and the sterility result was invalidated without adequate scientific justification before lot release. FDA found the company’s responses insufficient and its quality systems inadequate.

FDA Warning Letter: Rohto cited for falsified monitoring records and aseptic processing failures

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FDA’s April 2026 inspection of Rohto-Mentholatum (Vietnam) Co., Ltd. identified significant CGMP violations in the manufacture of aseptically processed OTC ophthalmic drugs. FDA observed systemic falsification of environmental monitoring, personnel monitoring, and cleaning records, including submission of unexposed plates and documentation of cleaning that management confirmed was not performed. After FDA discussed these deficiencies with management, monitoring conducted during the inspection produced numerous samples with microbial growth, including approximately 25 ISO 5 excursions. FDA also observed poor aseptic practices, undocumented interventions, deficient gowning, reuse of opened sterile component bags, infrequent decontamination, inadequate supervisory oversight, and equipment placement that obstructed unidirectional airflow. Investigations of two batches exceeding visual-inspection reject limits did not adequately identify the nature or source of particles, yet the batches were released to the U.S. market. FDA found the company’s response inadequate, citing reliance on unreliable monitoring data and insufficient consideration of systemic data integrity failures. The company subsequently initiated recalls due to lack of sterility assurance and suspended U.S.-market production.

FDA Warning Letter: Hanlim Pharm cited for sterile manufacturing and quality system deficiencies

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FDA cited significant CGMP violations following an April 2026 inspection of Hanlim Pharm’s drug manufacturing facility. Inspectors observed poor aseptic practices, including operators obstructing first air, working directly over exposed components, and wearing a visibly stained gown. Dynamic smoke studies did not demonstrate adequate unidirectional airflow protection and indicated possible entrainment of lower-quality air into the ISO 5 processing line. FDA also found that critical container-closure contact surfaces were wiped with sporicidal disinfectants rather than sterilized. Environmental monitoring locations and frequencies were not adequately justified or sufficient to detect contamination risks near containers, closures, and barriers facing ISO 5 areas. The visual inspection program lacked routine defect categorization and appropriate acceptance criteria despite significant defect rates. FDA further stated that the quality unit lacked adequate authority and oversight, citing failures involving the stability program and contemporaneous documentation of environmental and personnel monitoring data. FDA considered the company’s responses inadequate and noted similar violations in a previous warning letter.

FDA Warning Letter: Sterility, Component Testing, and Quality Unit Deficiencies at Jiangmen Shuizirun

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FDA states that its November 3–7, 2025, inspection of Jiangmen Shuizirun Sanitary Articles found significant CGMP violations in OTC drug manufacturing. Several products were labeled “sterile,” although they were not sterilized, the certificates of analysis did not claim sterility, and the firm did not perform release sterility testing. One released batch had a reported aerobic microbial count, which FDA said was unacceptable for a sterile-labeled drug. FDA also found inadequate identity and impurity testing for incoming components and purchased in-process materials, including high-risk ingredients, while supplier certificates were relied upon without establishing their reliability. The quality unit did not adequately oversee documentation, written production procedures, process and system validation, stability testing, or finished-product testing. FDA additionally noted that the same batch number was assigned to different products, and that neither the firm nor its U.S. Agent responded to FDA’s attempts to discuss recalling sterile-labeled products in U.S. distribution.

FDA cites CGMP violations at Jiangmen Shuizirun OTC drug facility

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FDA issued a warning letter to Jiangmen Shuizirun Sanitary Articles Co., Ltd. after a November 2025 inspection of its Chinese OTC drug manufacturing facility identified significant CGMP violations. FDA stated that products labeled “sterile” were not sterilized, lacked release sterility testing, and were assessed against microbial limits unacceptable for sterile drugs. The agency also cited inadequate identity and impurity testing of incoming components, reliance on supplier certificates without establishing reliability, and deficient quality-unit oversight of documentation, process validation, procedures, stability, and finished-product testing. FDA additionally identified non-unique batch numbering, recommended removal of within-expiry sterile-labeled products from the U.S. market, and noted that the firm’s drugs were placed on Import Alert 66-40.

EU GMP Non-Compliance (4 reports published for the same company- see previous posts): Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting – inadequate OOS and aseptic controls

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Following inspections on 10–12 February and 22–23 April 2026, the Netherlands Health and Youth Care Inspectorate found the hospital pharmacy GMP non-compliant. The NCA recorded one critical, seven major and 14 other deficiencies. The critical deficiency concerned an inadequate OOS process: multiple batches of registered finished products were released despite moisture or assay results outside specified limits, and an ATMP was released despite a failed in-process sterility test. The OOS procedure could permit certification and release without thorough investigation or sufficient justification. Major findings included inadequate aseptic controls, contamination control strategy, process simulations, microbiological investigation and trending, cleanroom behaviour and gowning. Weaknesses also affected the PQS, deviations, CAPA, change control, complaints, self-inspection, PQRs, computerized system validation, data integrity and documentation. The NCA’s stated action was withdrawal of four GMP certificates covering Plesmanlaan and Louwesweg. An unscheduled re-inspection is planned based on the company’s action plan. For the M22BOL study, the NCA described limited impact and left decisions to concerned Member States; no implemented suspension was reported.

EU GMP Non-Compliance: Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting – Inadequate OOS controls and release after failing results

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The Netherlands Health and Youth Care Inspectorate found the hospital pharmacy GMP non-compliant after inspections on 10–12 February and 22–23 April 2026. The conclusion was based on one critical, seven major and 14 other deficiencies. The critical deficiency concerned an inadequate OOS process: several registered finished-product batches were released despite moisture-content or assay results outside specified limits, and an investigational ATMP was released after a failed in-process sterility test. The OOS procedure could also permit certification and release without thorough investigation or sufficient justification. Major findings covered incomplete aseptic controls and contamination strategy, inadequate process simulations, weak microbiological investigation and trending, operator and gowning practices, deficiencies across the pharmaceutical quality system, inadequate computerized-system validation and data integrity, and poor documentation practices. The Inspectorate withdrew current GMP certificates, including certificates covering Louwesweg 6. A re-inspection, not yet scheduled, is planned against the company’s action plan; a new certificate would follow a positive outcome. For study EU CT 2023-505039-11-00, the NCA considered impact limited and left market decisions to concerned Member States.

EU GMP Non-Compliance: Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting – Inadequate OOS handling and aseptic controls

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Following inspections on February 10–12 and April 22–23, 2026, the Netherlands Health and Youth Care Inspectorate concluded that the hospital pharmacy was GMP non-compliant, citing one critical, seven major and fourteen other deficiencies. The critical deficiency concerned inadequate OOS handling: registered finished-product batches were released outside moisture or assay limits, and an ATMP was released despite a failed in-process sterility test. Major findings covered incomplete contamination controls, inadequate aseptic process simulations, deficient microbiological investigation and trending, poor cleanroom behaviour and gowning, and weaknesses in the pharmaceutical quality system, computerized system validation, data integrity and documentation. The NCA stated withdrawal of four current GMP certificates, including certificates for Plesmanlaan 121. A reinspection is planned but not yet scheduled; successful reinspection would support a new certificate and withdrawal of the non-compliance statement. For trial EU CT 2023-505039-11-00, the NCA assessed the impact as limited and left market decisions to concerned Member States; no trial suspension was reported.

Greenwich Rx Recalls Compounded Glutathione for Potential Elevated Endotoxin

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Greenwich Rx, a 503A compounding pharmacy, announced a voluntary nationwide consumer-level recall of ten lots of compounded glutathione injection 200 mg/mL in 10 mL multidose vials because of potential elevated endotoxin levels. The affected product was intended for subcutaneous injection and was distributed to patients from June 26 through September 21, 2026, with beyond-use dates from October 2 through November 12, 2026. The stated risks include fever, hypotension, inflammatory reactions, anaphylactic shock, and death. The company reported that two patients required emergency department care after intravenous administration of a glutathione product not formulated for IV use. Customers were instructed to stop using recalled product and follow disposal directions. The recall is being conducted with FDA’s knowledge.

FDA Cites Sterile Injectable CGMP Violations at Fresenius Kabi Facility

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FDA issued a warning letter to Fresenius Kabi AG after a January 27 to February 18, 2026 inspection identified significant CGMP violations at its Melrose Park sterile injectable facility. FDA cited inadequate investigations of endotoxin and bioburden signals, media fill failures, complaints, and biological particulate contamination; deficient aseptic process simulations and cleanroom practices; and inadequate visual inspection, facility, and equipment controls. The letter states that investigations overrelied on passing finished-product tests and lacked supported root causes, broad scope, and CAPA effectiveness checks. It also describes recalls of three famotidine injection batches and, following FDA discussions, six batches of other injectable products. FDA requested independent assessments, retrospective reviews, remediation plans, and a response within 15 business days.