FDA 483 - Zhejiang Huazhou Pharmaceutical Co., Ltd. - March 22, 2018

Zhejiang Huazhou Pharmaceutical Co Ltd, an API intermediate manufacturer in Jiaojiang District, P.R.C., was cited with eight observations during an FDA inspection. The inspection revealed significant issues across laboratory systems, production, facilities, and material control, including failures in OOS investigations, inaccurate logs, inadequate equipment controls, and improper material labeling. These findings indicate a lack of robust quality control and data integrity practices.