FDA 483 - Nanjing Cuccess Pharmaceutical Co., Ltd. - March 21, 2025

Nanjing Success Pharmaceutical Co., Ltd. in Nanjing, China, was cited for three significant observations during an FDA inspection. The firm failed to adequately clean and maintain equipment, did not follow written procedures for routine equipment checks, and deviated from its stability testing program by assigning shelf-lives without proper accelerated studies. These issues indicate a lack of control over manufacturing processes and product quality.