FDA 483 - Zhejiang Charioteer Pharmaceutical Co. Ltd. - January 15, 2018

An FDA inspection of Zhejiang Charioteer Pharmaceutical Co., Ltd., an API manufacturer in Zhejiang Province, China, revealed significant deficiencies in quality control. The firm failed to conduct complete investigations into out-of-specification results and customer complaints. Additionally, process parameters for cleaning and water manufacturing validation were not fully established or adequately controlled.