FDA 483 - Qingdao Kangyuan Pharmaceutical Co. Ltd.

An FDA inspection of Qingdao Kangyuan Pharmaceutical Co., Ltd in Qindao, China, revealed numerous deficiencies in their API production. Key issues included inadequate product testing against USP standards, lack of validated stability and impurity profiling methods, and poor control over manufacturing processes and equipment. The findings indicate significant gaps in the firm's quality management system and adherence to good manufacturing practices.