FDA 483 - Zhejiang Huahai Pharmaceutical - August 03, 2018

An FDA inspection of Zhejiang Huahai Pharmaceutical Co., Ltd. revealed significant deficiencies across its quality, production, and laboratory systems. The firm demonstrated inadequate change control, insufficient process and cleaning validation, and poor deviation investigation practices. These issues indicate a systemic failure to ensure the quality and purity of Active Pharmaceutical Ingredients (APIs) manufactured at the facility.