FDA Warning Letter: SCA Pharmaceuticals cited for aseptic processing and contamination-control deficiencies

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FDA states that its October 20–30, 2025, inspection of SCA Pharmaceuticals’ Little Rock outsourcing facility found serious deficiencies in production of drugs intended or expected to be sterile. Investigators cited inadequate certification and dynamic airflow visualization of ISO 5 areas, airflow and HEPA-supplied positive-pressure concerns, poor aseptic practices, deficient material disinfection, and environmental monitoring that was not representative of production conditions. FDA also found inadequate evaluation of microbial contamination in ISO 5 areas and insufficient investigations, CAPA, and batch-impact assessments. Component and visual inspection controls did not adequately identify, classify, investigate, trend, or address particles and foreign material between syringe stopper ribs. Laboratory controls and Quality Unit procedures were cited as inadequate. Production videos used in investigations were overwritten after approximately a redacted period, with only still images retained. FDA found some responses deficient and could not fully evaluate others because supporting documentation was inadequate, and recommended a comprehensive aseptic operations assessment assisted by a qualified sterile-manufacturing consultant.

FDA Warning Letter: Microbiological Data and Quality Unit Deficiencies at Eurofins SF Analytical Laboratories

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FDA states that its June 1–3, 2026 inspection of Eurofins SF Analytical Laboratories’ contract testing facility identified significant finished-drug CGMP violations in microbiological testing and quality oversight. Analysts did not record certain results assessed as too numerous to count and selectively documented results, while cracked and desiccated plates were reported as within limits or as 0 CFU. FDA also observed a colony on a plate recorded as 0 CFU. The procedure did not require secondary verification of initial zero counts, and compromised plates were discarded without secondary review. FDA found that aberrant media conditions were not thoroughly investigated; the firm’s retrospective conclusions relied on interviews and records it acknowledged were unreliable, without photographic evidence of plate conditions. FDA considered the response inadequate because it did not assess effects on certificates of analysis or customers, verify historical data completeness, or commit to discontinuing damaged plates. FDA further stated that the quality unit lacked adequate authority, oversight, and control over laboratory operations and requested independent assessments, CAPA, stronger investigation systems, sample custody controls, photographic documentation, and quality-unit remediation.

FDA Warning Letter: Microbiological OOS Investigations and Quality Unit Oversight at Silgan

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FDA inspected Silgan Unicep Packaging’s Spokane, Washington, drug manufacturing facility from March 26 to April 2, 2026, and reported significant CGMP violations involving non-sterile OTC products. FDA found that the firm inadequately investigated OOS microbiological results for components. Individual yeast and mold failures were invalidated by averaging sample results to obtain passing outcomes, and the sampling plan was revised to permit averaging, which FDA said was inconsistent with USP and could obscure non-uniform contamination. Affected component lots were released and used in distributed product. FDA also found the investigation associated with a Class I recall for potential fungal contamination inadequate: a bioburden-reduction corrective action was ineffective, related change control lacked appropriate validation and evaluation, the manufacturing line lacked cleaning procedures and cleaning validation, and environmental monitoring omitted yeast and mold testing. Separately, FDA said the quality unit failed to ensure supplier test reliability, follow the written stability program, and complete annual product reviews. FDA deemed the responses inadequate because they lacked sufficient scope, supporting evidence, effectiveness verification, product-risk measures, and remediation of systemic quality oversight failures.

Par Health Recalls Two Brevital Sodium Lots for Cellulose Particulate Matter

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Par Health announced a voluntary nationwide recall to the hospital level of two lots of Brevital Sodium 500 mg/vial CIV (Methohexital Sodium for Injection, USP) after particulate matter identified as cellulose was found. The affected lots are 86930, expiring February 2028, and 88623, expiring April 2028; they were distributed to wholesalers nationwide between July 8, 2025, and May 11, 2026. Par said use could cause life-threatening vascular consequences, although it had received no related adverse-event reports. Wholesalers and hospital pharmacies were instructed to stop use and distribution immediately, notify downstream accounts, and return inventory through Inmar. FDA posted the company announcement and noted that posting does not constitute endorsement.

FDA Finalizes Guidance on Postapproval Manufacturing Changes for Biosimilars

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FDA announced the availability of final industry guidance titled “Postapproval Manufacturing Changes to Biosimilar and Interchangeable Biosimilar Products: Questions and Answers.” The question-and-answer guidance addresses commonly asked questions from applicants and other interested parties about postapproval manufacturing changes to biosimilar and interchangeable biosimilar products licensed under the Public Health Service Act. It finalizes the draft guidance with the same title issued on July 23, 2024. The guidance was issued by FDA’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research under docket FDA-2024-D-2581. The source identifies it as Final Level 1 Guidance.

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.

EU GMP Non-Compliance: Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting – inadequate OOS handling allowed release of non-compliant batches

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Following its 2026 inspection, the Netherlands Health and Youth Care Inspectorate found the hospital pharmacy GMP non-compliant for sterile, non-sterile, biological and packaging operations. The NCA recorded one critical, seven major and 14 other deficiencies. The critical deficiency concerned an inadequate OOS process: several registered finished-product batches were released outside moisture or assay limits, and an ATMP was released after a failed in-process sterility test; ambiguous procedures could permit certification without adequate investigation or justification. Major findings covered incomplete aseptic controls and contamination strategy, inadequate process simulations, weak microbiological test design, investigation and trending, operator and gowning deficiencies, an insufficient pharmaceutical quality system, inadequate computerized-system validation and data integrity, and poor documentation practices. For the sole EU-facing study, DS-8201a relabeling and repackaging, the NCA considered impact limited but said systemic deficiencies could affect it. It left market decisions to concerned Member States; no trial suspension was stated. The NCA withdrew four GMP certificates and plans an as-yet-unscheduled re-inspection. Positive re-inspection would permit recertification and withdrawal of the statement.

EU GMP Non-Compliance: Ocb Pharmaceutical S.R.L. – relabelling and distribution obscured bismuth subsalicylate supply-chain traceability

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Following an inspection ending 27 August 2026, the Spanish NCA identified nine deficiencies: one critical and eight major. The critical deficiency concerned repackaging and relabelling bismuth subsalicylate from a Chinese manufacturer operating outside the EU GMP framework. OCB assigned new batch numbers, copied supplier results into certificates of analysis, replaced or removed original labels, and distributed material without adequately preserving manufacturer identity and supply-chain traceability. Major deficiencies affected investigations, CAPA, risk management, data integrity, personnel qualification, materials traceability, contamination controls, cleaning, facilities, documentation and quality oversight. The NCA temporarily suspended all API and intermediate manufacturing at Canovelles and suspended distribution and sale of material manufactured, repackaged or relabelled there, pending correction and verification through reinspection. No recall was considered necessary because no specific defects in marketed batches were detected. The NCA said suspension of the site’s bismuth subnitrate CEP should be considered. It also withdrew the current GMP certificate and recommended justified testing by customers, alternative qualified sources, and exclusion from new or ongoing applications while the statement remains in force.