FDA 483 - Zhejiang Huahai Pharmaceutical Co., Ltd. - May 31, 2019

This FDA Form 483 was issued to Zhejiang Huahai Pharmaceutical Co. Ltd. in Linhai, China, an API and drug product manufacturer, following an inspection from May 20-31, 2019. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate analytical method validation, a scientifically unsound cleaning validation program, and insufficient evaluation of the solvent recovery process. Additionally, the firm failed to adequately identify unknown peaks, initiate investigations into manufacturing deviations, and implement effective corrective and preventative actions for complaint investigations.