FDA 483 - Zhejiang Tianyu Pharmaceutical Co., Ltd. - November 29, 2024

During an FDA inspection conducted from November 21-29, 2024, at Zhejiang Tianyu Pharmaceutical Co., Ltd., an Active Pharmaceutical Ingredient (API) manufacturer in Huangyan, China, several significant observations were noted, indicating deviations from expected manufacturing and quality control standards. The primary issues revolved around inadequate laboratory controls and quality system failures. Specifically, the firm failed to establish proper impurity profiles for identified and unidentified impurities, particularly in recovered material testing. Investigators observed that the Quality Control department consistently did not integrate or investigate unknown peaks during analysis, contrary to their own procedures and general good practice for understanding product quality. There was also a lack of procedures for handling unknown peaks in intermediates, recovered solvents, and raw materials. Furthermore, the inspection highlighted a failure to clean equipment, specifically recovered solvent and material storage tanks, at appropriate intervals. This lapse creates a risk of contaminant and degradant build-up and carryover into subsequent manufacturing stages. The company's internal cleaning procedures were found to be conflicting, leading to practices where tanks were reused multiple times without proper cleaning. These observations require Zhejiang Tianyu Pharmaceutical Co., Ltd. to implement comprehensive corrective and preventive actions to ensure compliance with regulatory standards under the Federal Food, Drug and Cosmetic Act.