Supplier Qualification

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: 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.

FDA Warning Letter: SnugZ USA cited for OOS, laboratory, supplier, and quality unit deficiencies

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FDA states that its April 27 to May 1, 2026 inspection of SnugZ USA’s OTC drug manufacturing facility identified significant CGMP violations. The firm routinely failed to investigate out-of-specification chemical and microbiological results, instead retesting or preparing new samples until passing results were obtained and using those results for product release. Complaint investigations lacked adequate root cause determinations and CAPA. Laboratory procedures permitted repeated testing without investigations and allowed analysts discretion regarding unidentified chromatographic peaks. FDA also found unsupported tiered microbiological testing, with failing results invalidated in favor of passing results from a second instrument. Incoming components were not adequately identity-tested or representatively sampled, and supplier certificates of analysis were accepted without establishing their reliability through confirmatory testing. FDA further states that the quality unit did not adequately oversee manufacturing, testing, records, investigations, release decisions, cleaning validation, or product quality reviews. Similar investigation and laboratory-control deficiencies had been observed previously, and FDA considered the firm’s remediation responses insufficiently detailed and sustainable.

FDA Warning Letter: Sterility, Component Testing, and Quality Unit Deficiencies at Jiangmen Shuizirun

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FDA states that its November 3–7, 2025, inspection of Jiangmen Shuizirun Sanitary Articles found significant CGMP violations in OTC drug manufacturing. Several products were labeled “sterile,” although they were not sterilized, the certificates of analysis did not claim sterility, and the firm did not perform release sterility testing. One released batch had a reported aerobic microbial count, which FDA said was unacceptable for a sterile-labeled drug. FDA also found inadequate identity and impurity testing for incoming components and purchased in-process materials, including high-risk ingredients, while supplier certificates were relied upon without establishing their reliability. The quality unit did not adequately oversee documentation, written production procedures, process and system validation, stability testing, or finished-product testing. FDA additionally noted that the same batch number was assigned to different products, and that neither the firm nor its U.S. Agent responded to FDA’s attempts to discuss recalling sterile-labeled products in U.S. distribution.

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.

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: 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 Stream2Sea for OTC Drug Manufacturing CGMP Violations

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FDA issued a warning letter to Stream2Sea LLC after a July 2025 inspection identified significant CGMP violations in finished OTC drug manufacturing. FDA cited inadequate final-product chemical and microbiological testing before batch release, including release before documented quality-unit approval. The agency also found missing identity testing of incoming components, reliance on supplier certificates of analysis without establishing supplier test reliability, and no supplier qualification program. FDA further cited inadequate cleaning validation and records for shared, non-dedicated equipment used for OTC drugs and cosmetics. It requested independent assessments, remediation plans, specifications, procedures, retrospective evaluations, and a written response within 15 working days.

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 Warns Kellin Chemicals Over Refused API Facility Inspection

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FDA issued a warning letter to Kellin Chemicals (Zhangjiagang) Co., Ltd., an establishment registered as an active pharmaceutical ingredient supplier to finished-drug manufacturers serving the U.S. market. The firm’s U.S. agent told FDA that the company refused a preannounced inspection planned for July 7–11, 2025. FDA states that drugs made, processed, packed, or held there are adulterated under section 501(j) because inspection was refused. FDA may withhold application or supplement approvals listing the facility and may detain or refuse relevant U.S. shipments. The company was asked to respond within 15 working days and could request an inspection.