OOS / OOT

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.

FDA Warning Letter: VeganicSKN OOS, Component Testing, and Quality Unit Deficiencies

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FDA stated that its July 2025 inspection of VeganicSKN Limited found significant CGMP violations. The firm delayed a Phase II investigation of an out-of-specification result from August 2024 until December 2024, released and shipped the batch after passing retest results, and closed the investigation in July 2025 without determining a root cause. FDA found the response inadequate because it did not justify the nearly 11-month investigation or comprehensively assess other OOS investigations. FDA also observed inadequate identity testing of a high-risk incoming component, reliance on supplier certificates of analysis without establishing their reliability, and use of an expired raw-material lot. The response did not adequately address affected distributed products, other at-risk components, or interim controls. FDA further stated that the quality unit lacked adequate authority, procedures, and oversight; production personnel performed functions that should be quality-assurance responsibilities, and bulk hold-time validation studies were not completed. FDA also raised concerns about closely integrated entities sharing facilities, utilities, equipment, systems, personnel, and management.

FDA Warns Bentley Laboratories Over CGMP, Testing, and Validation Failures

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FDA issued a warning letter to Bentley Laboratories following a March 2026 inspection, citing significant CGMP violations for finished pharmaceuticals. FDA found inadequate investigations of out-of-specification stability and cleaning results, deficient root-cause analysis and CAPA, unjustified specification changes, and insufficient quality-unit oversight. The agency also cited inadequate incoming-component identity and impurity testing, reliance on supplier certificates of analysis without establishing reliability, and weaknesses in supplier qualification. Manufacturing and cleaning processes were not adequately validated or revalidated after changes, and validation protocols were not fully executed. FDA also determined that two acne products were unapproved new drugs and misbranded, and acknowledged the firm’s commitment to suspend certain OTC drug production.

FDA Warning Letter: KDC/ONE Chatsworth cited for testing, OOS investigation, and storage deficiencies

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FDA inspected KDC/ONE Chatsworth’s drug manufacturing facility from March 31 to April 3, 2026, and cited significant CGMP violations involving OTC finished pharmaceuticals. The agency states that the firm lacked scientifically sound finished-product specifications and did not perform specified contaminant testing at release or during stability studies, despite known degradation and reaction pathways and notification of contamination linked to products recalled in Canada. FDA said the firm did not determine whether recalled batches reached the United States, assess U.S. consumer risk, identify other potentially affected batches, or demonstrate that its proposed third-party laboratory was qualified. FDA also observed inadequate investigations of viscosity OOS stability results, including insufficient root-cause determination, CAPA, specification justification, and risk assessment for distributed products. In addition, FDA found inadequate warehouse temperature monitoring and procedures, including storage above labeled conditions and internal limits. FDA considered the firm’s responses inadequate and stated that the quality unit was not able to fully exercise its authority and responsibilities.