Records Failures Uncovered at Chinese API Maker

FDA investigators found API production records all over the floor, desks and cabinets of the quality unit in Yibin Lihao Bio-technical’s Sichuan, China facility.

When first asked about the records, the firm denied that they were “production records for real products” but said they were created for a “government project that would allow the firm to apply for government funding,” the Form 483 said.

An FDA investigator found what appeared to be production in-process testing records, but the production supervisor “proceeded to grab the records from my hands,” the inspection report said. The QA manager later explained that batches manufactured in the crude workshop were not for companies that manufactured drugs, but were for testing equipment and selling to companies that manufactured products such as cosmetics.