FDA 483 - Zhejiang Huahai Pharmaceutical Co., Ltd.

An FDA inspection of Zhejiang Huahai Pharmaceutical Co., Ltd. in Linhai, China, revealed critical deficiencies across its drug manufacturing operations. The firm failed to maintain adequate cleaning procedures, validate aseptic processes, establish proper production controls, and ensure thorough investigations into product discrepancies. These widespread issues indicate a significant lack of control over manufacturing processes, posing risks to the quality and safety of drug products for the US market.