FDA 483 - Zhejiang Tianyu Pharmaceutical Co. Ltd. - April 12, 2019

An FDA inspection of Zhejiang Tianyu Pharmaceutical Co Ltd, an Active Pharmaceutical Ingredient (API) manufacturer, revealed significant deficiencies across its quality systems, facilities, and production processes. The firm failed to conduct adequate investigations into product contamination and customer complaints, lacked proper quality agreements with contract laboratories, and exhibited critical shortcomings in cleaning and process validation. Additionally, the facility's warehouse for API storage was found to be in a poor state of repair.