Drugs

CGMP Violations at Jiangmen Shuizirun

An 11/3-11/7/2025 FDA inspection at the Jiangmen Shuizirun Sanitary Articles Co. drug manufacturing site in Jiangmen, Guangdong, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 9/23 Warning Letter lists the violations as:

failure to establish procedures designed to prevent micro-contamination in products purporting to be sterile;
failure to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality, and failure to validate and establish the reliability of component suppliers’ test analyses at appropriate intervals; and
failure of the firm’s quality control unit to exercise its responsibility to ensure manufactured drug products comply with CGMP and meet established specifications for identity, strength, quality, and purity.

The letter says FDA attempted to contact the firm on 2/3, 2/4, and 2/5 to request a teleconference to discuss recalling a redacted drug labeled as sterile, within expiry, and currently in distribution in the U.S. “To date,” it says, “neither you or your U.S. agent have responded to any of our attempts for direct contact.” The agency recommends that the company remove any batches of the product from the U.S. market.

FDA recommends that Jiangmen engage a qualified consultant to conduct a comprehensive, six-system audit of its entire operation, assist it in meeting CGMP requirements, and evaluate the completion and efficacy of its corrective and preventive actions before it pursues resolution of its compliance status with FDA.

FDA placed all of Jiangmen’s drugs offered for import into the U.S. on a 4/20 Import Alert.

The company was told to address the violations without delay and to ensure that appropriate resources are allocated to fully address the violations and prevent their recurrence.

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