FDA 483 - Zhejiang Kangle Pharmaceutical Co., Ltd (Binhai Plant) - March 22, 2019

An FDA inspection of Zhejiang Kangle Pharmaceutical Co Ltd, a finished dose intermediate manufacturer in Wenzhou, Zhejiang, PRC, revealed significant deficiencies. Observations included failures in securing and controlling cleaning documents, inadequate cleaning procedures and documentation, and a lack of proper training for production employees on deviation reporting. These issues suggest a concerning lack of adherence to established quality control protocols.