FDA 483 - Sichuan Huiyu Pharmaceutical Co., Ltd. - July 18, 2022
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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