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Talk to a SpecialistTalk to a SpecialistSichuan Deebio Pharmaceutical Co. Ltd. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of Active Pharmaceutical Ingredients (APIs), rendering their products adulterated. During an FDA inspection in September 2023, investigators found that the company's Quality Control microbiology laboratory failed to read and record microbiological test results contemporaneously, with QC personnel relying on memory rather than documenting results at the time of testing and providing conflicting accounts of the procedures followed. The firm's failure to maintain data integrity and follow established laboratory procedures violated CGMP requirements for documentation and control of manufacturing operations.