China NMPA Inspection - Sichuan Xichang Yangtian Pharmaceutical Co., Ltd. - December 08, 2016

Sichuan Xichang Yangtian Pharmaceutical Co., Ltd. underwent an unannounced inspection from October 24-26, 2016, by the State Food and Drug Administration and Sichuan Provincial Food and Drug Administration, prompted by case clues. The inspection uncovered significant violations of the "Drug Administration Law of the People's Republic of China" and relevant Good Manufacturing Practice (GMP) regulations. Key issues included pervasive inaccuracies in batch production records, with discrepancies between recorded and actual powder batch numbers for Wanying Capsules. Laboratory data was also found to be inaccurate, featuring inconsistent HPLC chromatograms, missing raw data files, and a failure to report an E. coli positive test result for a product batch. Furthermore, the company was suspected of illegally adjusting the content of Wanying Capsule powder through the addition of berberine hydrochloride, indicated by internal computer records. Material management was chaotic, with finished products stored in an unauthorized warehouse, raw materials lacking traceability, and ink procured from an unlicensed supplier. Supplier quality records were incomplete, and discarded packaging and substandard materials were poorly managed. As a result of these serious findings, regulatory authorities mandated the sealing of all Wanying Capsules inventory, revocation of the company's Drug GMP Certificate, recall of all distributed products, and a full investigation into the company's illegal production practices.