Materials Management

FDA Warning Letter: TSP Solutions cited for testing, supplier oversight, and quality unit deficiencies

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FDA states that its review of records submitted by TSP Solutions identified significant CGMP violations involving sunscreen drug products. The firm did not demonstrate adequate finished-product testing before release. Submitted certificates of analysis and batch records lacked appropriate assays for active ingredient content, impurity testing, and appropriate microbiological testing. FDA also found that the firm did not demonstrate adequate identity testing of incoming components and accepted supplier certificates of analysis without verifying test results at appropriate intervals. Component quality verification consisted only of reviewing supplier certificates and material safety data sheets. In addition, FDA stated that the firm had not established an adequate quality unit with sufficient responsibilities and authority to oversee drug manufacturing. The quality unit failed to ensure adequate production and process control procedures, qualification of manufacturing equipment, laboratory control procedures, and an adequate ongoing stability program. FDA recommended a qualified CGMP consultant and a comprehensive six-system audit. The firm’s drugs were placed on Import Alert 66-40 on August 14, 2026.

FDA Warning Letter: Sanrace cited for component testing, process validation, and quality unit deficiencies

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FDA’s records review of Sanrace Biotechnology found significant CGMP violations involving component testing, process control, and quality-unit oversight for OTC drug manufacturing. FDA states the firm did not demonstrate adequate identity testing of incoming components, including an active ingredient, and did not perform the USP identification test capable of detecting specified hazardous impurities on each shipment of each lot. FDA said this left the firm without scientific evidence that components met appropriate specifications before use. The firm’s response also stated that it had no process validation procedures or studies, so it did not demonstrate reproducible, controlled manufacturing yielding uniform quality. FDA further found that the quality unit was not established with adequate responsibility and authority over manufacturing. Cited examples included inadequate laboratory control procedures, an inadequate system monitoring program with insufficient attribute testing, and an inadequate ongoing stability program. Submitted records lacked complete stability data and testing for viscosity, pH, assay, and microbiological attributes throughout shelf life. FDA placed the firm’s drugs on Import Alert 66-40.

FDA Warning Letter: Component Testing and Quality Unit Deficiencies at Zhejiang Gaorong Cosmetic

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FDA identified significant CGMP violations during a review of records submitted by Zhejiang Gaorong Cosmetic Co., Ltd., an OTC drug manufacturer. The firm did not demonstrate adequate testing of every shipment of each incoming component lot before use. Documentation lacked adequate identity and impurities testing for redacted components described as being at risk or high risk for contamination. The firm also accepted active pharmaceutical ingredients based on supplier certificates of analysis without establishing the reliability of supplier testing at appropriate intervals. FDA stated that this left the firm without scientific evidence that components or drug products met appropriate specifications before use. FDA also found that the quality unit did not effectively oversee drug manufacturing operations, including ensuring complete batch-production records and adequate stability data supporting product expiry. FDA requested component testing and supplier-reliability plans, contract laboratory oversight, risk assessment and testing for implicated materials and products, supplier and material-system review, and comprehensive quality-unit remediation.

EU GMP Non-Compliance: Glukem Biocare Private Limited – contamination risk in cleaned fluid-bed coating equipment

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After the inspection ending 15 September 2026, the Malta Medicines Authority considered the site non-compliant for non-sterile pellet manufacture and quality-control testing. A critical deficiency concerned contamination risk in cleaned fluid-bed coating equipment: liquid pooling and residue were observed in an inlet-air plenum. The authority linked this to a design that prevented gravity drainage and an inadequate cleaning procedure. There was also no real-time differential-pressure monitoring before and after the supply-air HEPA filter to detect integrity failure. Eleven major findings covered production records, process and cleaning validation, differential-pressure excursions, warehouse, sampling and dispensing controls, vendor qualification, starting-material identification, excipient risk assessments, OOS handling, equipment qualification and pest control. The authority stated that no site-manufactured batches should be released to EEA markets while the statement remains in place, unless superseded by an EU GMP certificate. Under the revocation heading, it recommended that member states consider not initiating or authorising new marketing authorisations listing the site; it did not state that existing authorisations were revoked. The authority said products should not be present in EEA markets and did not propose a teleconference.

Par Health Recalls 22 Argatroban Injection Lots for Particulate Matter

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Par Health USA announced a nationwide, hospital/user-level recall of 22 lots of Argatroban Injection 250 mg/2.5 mL (100 mg/mL) after particulate matter was detected in certain lots. Identified materials included cellulose, polystyrene, polyethylene terephthalate, stopper material, and possibly stainless steel. The affected lots were distributed to wholesalers and hospitals between December 30, 2024, and May 5, 2026. Par Health stated that administration of affected product could cause life-threatening vascular and inflammatory consequences. No related adverse events had been reported. Wholesalers and hospital pharmacies were instructed to discontinue use and distribution immediately and return existing inventory.

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.

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.

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: 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.