Quality Unit

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 Warning Letter: Inadequate Testing, Process Validation, and Quality Unit Oversight at TCI BioCosme

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FDA states that its March 2026 inspection identified significant CGMP violations in the manufacture of OTC drug products. The firm released U.S.-market batches without finished-product assay testing for the active ingredient, and its quality system did not ensure that required tests were identified, documented, and completed. FDA also observed inadequate identity testing of incoming APIs and raw materials, reliance on supplier certificates of analysis without establishing their reliability, and failure to perform applicable USP monograph tests. Manufacturing processes were not adequately validated: a validated process differed from the batch record, and validation for one product was used to support another product with a different process. Qualification and monitoring of a component used in products and equipment cleaning lacked specified chemical and microbial testing and defined microbial limits. FDA further cited inadequate quality unit oversight, including undocumented process-parameter changes, deficient batch records, and the absence of a written stability testing program. FDA found the firm’s Form FDA 483 response inadequate because it lacked sufficient supporting documentation and evidence of corrective actions.

FDA Warning Letter: Babikian Healthcare Products cited for component, finished-product, and quality-unit deficiencies

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FDA reviewed records submitted by Babikian Healthcare Products CJSC in response to an August 12, 2025 request and identified significant CGMP violations involving its OTC drug manufacturing operations. The firm did not test the identity of each incoming component or validate the reliability of suppliers’ certificates of analysis at appropriate intervals. FDA also found no evidence that specified active ingredients met referenced USP limits. Finished-product reports lacked appropriate assay testing for active-ingredient identity and strength and for impurities; records also failed to demonstrate adequate microbiological testing for each batch before release. FDA stated that the quality unit did not adequately exercise its authority and responsibilities. It failed to ensure written production and process-control procedures for process performance and qualification of a system producing a component, complete manufacturing information in batch records, stability data supporting labeled expiration dates, and adequate quality-unit authority and procedures. FDA characterized the quality systems as inadequate and stated that the drug products were adulterated because manufacturing methods, facilities, or controls did not conform to CGMP.

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 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: 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.

FDA Warning Letter: Bausch & Lomb cited for aseptic processing and contamination-control deficiencies

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FDA states that its March 12–20, 2026 inspection of Bausch & Lomb’s Tampa drug manufacturing facility identified significant CGMP violations involving sterile prescription and OTC products. Environmental and personnel monitoring did not sufficiently cover significant locations, procedures were inadequate, and cracked media could not adequately support growth of recovered contamination. From 2023 to 2025, the firm routinely recovered out-of-limit microorganisms in ISO 5 areas, including gram-negative organisms associated with water sources, but continued production without adequate CAPA. FDA also cited inadequate investigations of microbiological departures and adverse trends, insufficient microorganism identification, RABS and barrier-design deficiencies, and smoke studies that did not sufficiently demonstrate unidirectional airflow. Operators were repeatedly observed using poor aseptic techniques during filling. Media fills were substantially smaller than commercial batches and did not adequately represent contamination risks; a July 2025 media fill failed with fungal and spore-forming bacterial contamination. FDA further stated that management oversight was ineffective and the quality unit lacked sufficient authority or implementation of its responsibilities.

FDA Warning Letter: Happy Farm Botanicals cited for component testing, stability, and validation failures

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FDA states that its March 30 to April 2, 2026, inspection of Happy Farm Botanicals’ OTC drug facility found significant CGMP violations. The firm did not perform specific identity testing on incoming raw materials and components, including APIs, before use; one API lot received only organoleptic testing and was used in finished batches. FDA also found a lapsed supplier requalification and no adequate validation of supplier test analyses. The stability program lacked adequate chemical and microbiological support for labeled expiry periods: accelerated studies lacked controlled humidity records, several timepoints were unavailable, and failing viscosity results in accelerated and long-term studies were not investigated. FDA’s quality unit findings included absent process validation for OTC products, absent cleaning validation for non-dedicated equipment, inadequate investigation and CAPA for recurring gasket seal failures, and inappropriate API content release limits. FDA deemed the firm’s response inadequate and noted that process and cleaning validation commitments from the 2024 inspection remained incomplete. The firm reported plans to cease production of the specified drugs at this facility.

FDA Warning Letter: Jabil sterile manufacturing deficiencies involving fungal contamination and quality oversight

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FDA’s February 23 to March 6, 2026, inspection of Pharmaceutics International, Inc., a Jabil company and contract manufacturer of sterile injectables, identified significant finished-pharmaceutical CGMP violations. FDA found inadequate investigations of a sterility failure involving Ustilago spermophora and recurring fungal recoveries in Grade A filling areas, including insufficient root-cause analysis, trend evaluation, and CAPA. The quality unit did not ensure complete documentation of aseptic interventions; one batch record documented 12 interventions although records indicated approximately 200 occurred. FDA also cited inadequate disinfectant efficacy studies and failure to perform process validation after adding a production step. Airflow visualization studies were deficient or omitted following RABS modifications, and some interventions lacked adequate smoke visualization. Environmental monitoring used insufficient sampling techniques and locations. Classified areas also had peeling paint and plastic debris. FDA considered the company’s responses inadequate because they did not sufficiently address contamination sources, systemic investigation weaknesses, quality oversight, or sustainable remediation.