What happened
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.
Why it matters
From a GMP manufacturing perspective, the findings may matter because sterile labeling must be supported by appropriate sterility assurance controls. The letter also highlights the importance of testing incoming components, establishing the reliability of supplier analyses, and maintaining effective quality-unit oversight. Unique lot identification is relevant to batch history and distribution traceability, while FDA’s requested risk assessments, recalls where appropriate, and CAPA address products already distributed and future supply-chain controls.
Key topics: Sterile-labeled OTC products without sterility assurance, Incoming component testing and supplier COA reliability, Quality-unit oversight and unique lot identification