FDA 483 - Tianjin Darentang Jingwanhong Pharmaceutical Co., Ltd. - March 22, 2024

The FDA conducted an inspection of TIANJIN DARENTANG JINGWANHONG PHARMACEUTICAL CO., LTD. from March 18 to March 22, 2024, revealing several significant observations related to Current Good Manufacturing Practices (GMP). The regulatory framework for these observations is primarily 21 CFR Part 211, pertaining to finished pharmaceuticals.

Key issues identified include a lack of written procedures for production and process controls, specifically the absence of protocol-driven process validation studies and equipment qualification for products distributed to the US market. The firm also failed to implement change management controls for modifications to procedures, processes, and equipment, and the Quality Unit did not review and approve changes.

Further deficiencies were noted in laboratory controls. Sterilization validation for equipment was deemed inadequate, lacking proper assessment parameters like suitable bacterial indicators, incubation temperatures, worst-case load configurations, and studies for various materials. Additionally, electronic raw data was not subject to a second-person review, and impurities were not evaluated during finished product or stability testing, with no forced degradation studies conducted.

Equipment maintenance was also cited, with observed residues and oil on "clean status" filling machines and chipped paint above a production area, indicating a risk of contamination. Lastly, reserve drug product samples were not visually examined annually for deterioration; only the secondary packaging was assessed. The company is required to address these deficiencies to ensure compliance with U.S. GMP regulations.