Sichuan Huiyu Pharmaceutical Co., Ltd. – FDA 483, Jul 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.
ID · a3bbe703-9950-4b1a-b424-24864e6a9626
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