FDA 483 - Zhejiang Huahai Pharmaceutical Co., Ltd. - June 28, 2019

Zhejiang Huahai Pharmaceutical Co. Ltd. in Linhai, China, an API and drug product manufacturer, was cited for significant deficiencies in its quality systems. Observations included incomplete investigations into product discrepancies, inadequate procedures for preventing microbiological contamination in sterile products, and failures in its change control system. The firm also had deficient master production records and laboratory control specifications.