What happened
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.
Why it matters
From a GMP perspective, sterile labeling without sterilization, sterility testing, or controls capable of assuring sterility may create uncertainty about microbiological quality and patient safety. Inadequate component identity and hazardous-impurity testing may allow unsuitable raw materials into production, particularly when supplier data have not been validated. Weak quality-unit oversight, incomplete process validation, and deficient stability and finished-product testing can undermine batch disposition and sustained control. Reused batch numbers may also impair traceability of manufacturing and distribution histories.
Key topics: Sterile-labeled OTC drugs without sterilization or release sterility testing, Inadequate component identity and hazardous-impurity testing, Quality unit oversight and batch traceability deficiencies