FDA 483 - Sichuan Huiyu Pharmaceutical Co., Ltd. - July 18, 2022

An FDA inspection of Sichuan Huiyu Pharmaceutical Co., Ltd., a sterile drug manufacturer in Neijiang, China, revealed two significant observations. The firm failed to maintain adequate laboratory controls, specifically regarding the execution of chromatography sequences for drug product testing. Additionally, the inspection found deficiencies in the firm's supplier qualification program, including insufficient material testing and lack of instructions for assessing supplier Certificates of Analysis.