FDA WARNING_LETTER - Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd. - March 22, 2024

The FDA issued a Warning Letter to Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd. following an inspection from March 18-22, 2024, which documented significant CGMP violations and inspection limitations/refusals.

The firm limited and refused the inspection by: * **Limiting Access to Records:** Providing unreasonably redacted manufacturing records (process validation reports, batch records, equipment qualification reports) and incomplete CAPA lists. * **Limiting Photography:** Prohibiting investigators from photographing dirty and disrepaired filling machines (ID-192, ID-197). * **Limiting Access to Areas:** Denying access to a manufacturing room where specific operations were performed.

These actions render the firm's drugs adulterated under section 501(j) of the FD&C Act.

Additional CGMP violations include: 1. **Failure to Clean and Maintain Equipment (21 CFR 211.67(a)):** Investigators observed residues and disrepair on filling machines (ID-192, ID-197) despite being marked "clean." The firm's response regarding revised cleaning procedures and repairs was deemed inadequate, lacking a comprehensive CAPA plan for oversight and a retrospective assessment of cleaning effectiveness. 2. **Failure to Establish Adequate Production and Process Controls (21 CFR 211.100(a)):** The