Data Integrity

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: 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.

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.

FDA Cites Curia New York for API Data Integrity and Computerized System Failures

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FDA issued a warning letter to Curia New York, Inc. after its January 28–February 5, 2026 inspection of the Rensselaer API manufacturing facility. It states the firm’s APIs are adulterated because manufacturing methods, facilities, or controls did not conform to CGMP. FDA cited incomplete laboratory records and thousands of unexplained HPLC/UPLC injections, including use of the Empower “Developer” role; discarded original records and review of photocopies; and shared computerized-system credentials. FDA found the firm’s responses inadequate in scope or supporting evidence. It requested independent investigations, retrospective data-integrity and computerized-system assessments, product-impact and risk evaluations, laboratory remediation, and a global CAPA plan.

FDA Warning Letter: Aseptic Processing and Media-Fill Deficiencies at Empower Pharmacy

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FDA states that its November 3-14, 2025, inspection found Empower Pharmacy’s compounded semaglutide and tirzepatide products did not meet section 503A conditions, making the ineligible products subject to CGMP. Investigators observed that sterile products were prepared under insanitary conditions. Smoke studies did not adequately demonstrate unidirectional airflow under dynamic conditions, and media fills were not conducted under the most challenging conditions. FDA also cited inadequate maintenance systems for equipment controlling aseptic conditions, deficient procedures to prevent microbiological contamination and validate aseptic and sterilization processes, inadequate environmental monitoring, insufficient production and process-control procedures, and failure of the quality control unit to ensure CGMP compliance and product specifications. In reviewing corrective actions, FDA said a revised smoke study remained unfinalized. It also identified unexplained vial-count discrepancies, missing or unclear media-fill records, undefined “N/A” entries, and transcription of original results onto a revised form without a clear audit trail, authorization, or justification.

FDA Warning Letter: Reliance Life Sciences cited for data integrity and aseptic processing deficiencies

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FDA’s February 19–27, 2026 inspection of Reliance Life Sciences’ Navi Mumbai drug facility identified significant CGMP violations involving laboratory data, sterile manufacturing, and quality oversight. FDA found environmental monitoring and other microbiology samples recorded as collected and incubated even though plates were absent and analysts confirmed the samples were not collected. LIMS calculations omitted required dilution factors, while electronic integrity-testing files lacked unique names and were overwritten; testing was also not performed for one plant. FDA said these deficiencies created a risk of underreported microbial findings and unreliable batch-release evidence. In aseptic operations, investigators observed operators blocking unidirectional airflow over critical locations and not discarding potentially compromised vials. FDA also observed deteriorated or damaged manufacturing areas or components, excess sealant near HEPA filters, nonsterile wipes used for cleaning, and standing water and staining near pipelines. FDA deemed the firm’s responses insufficient, citing incomplete remediation detail, traceability, oversight, and timelines. The company agreed to recall all sterile drugs and suspend U.S.-market production; FDA later placed its drugs on Import Alert 66-40.

FDA Warning Letter: Insanitary API Manufacturing, Incomplete Laboratory Data, and Weak Quality Oversight

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FDA states that its April 13 to 17, 2026 inspection of Shoolin Pharma Chem LLP found APIs prepared, packed, or held under insanitary conditions and identified significant API CGMP violations. Investigators observed layered unidentified residues, chemical residues and stains on walls, floors, equipment, and product-contact areas; corroded or apparently rusted surfaces; leaking lines; improperly stored transfer lines; and an employee wearing open-toed sandals near open equipment during production. Nondedicated equipment was used for multiple APIs. FDA also found inadequate written cleaning and maintenance procedures, no swab or rinse cleaning verification, and insufficient cleaning validation remediation. The firm could not provide raw data supporting certificate-of-analysis results, while contract-laboratory results were reported on company letterhead without identifying the original laboratory. Stability chambers were powered off or outside temperature or humidity conditions, supporting records were unavailable, and tadalafil samples were missing. FDA further cited inadequate quality-unit oversight of impurity risks, contract laboratories, process validation, equipment calibration, materials testing, and annual product reviews. The firm recalled all APIs distributed in the U.S., and FDA placed its drugs on Import Alert 66-40.