FDA 483 - Dongying Tiandong Pharmaceutical Co Ltd - October 19, 2018

An FDA inspection of Dongying Tiandong Pharmaceutical Co., Ltd., an API manufacturer in Dongying, China, revealed significant deficiencies in documentation and laboratory control. The firm failed to maintain adequate records for crude material supplier traceability and lacked complete laboratory control records, including raw data for real-time PCR assay validations. These issues indicate a lack of robust quality system controls.