China NMPA Inspection - Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd. - December 05, 2018

An unannounced inspection of Guangzhou Baiyunshan Tianxin Pharmaceutical Co., Ltd. revealed significant non-compliance with drug manufacturing regulations. The inspection, conducted as part of a national drug tracking plan (with findings published November 30, 2018), identified critical deficiencies in the production of cefotaxime hydrochloride for injection. Key violations included the unauthorized use of containers directly contacting the drug, leading to a recall of two product batches. The company demonstrated inadequate research into product characteristics and insufficient quality management, evidenced by a lack of monitoring for environmental factors like light and temperature during packaging, and incomplete records for critical process steps. Data analysis for product validation was found to be insufficient, and discrepancies in water for injection records were not promptly investigated. Issues extended to sample retention practices, improper classification of significant changes in the change management system, and missing training records for quality personnel. Furthermore, the inspection identified failures in dynamic monitoring of suspended particles in clean areas, and a contamination risk during powder mixing where operators entered high-grade sterile environments improperly. The monitoring system also showed implausible zero particle data for critical aseptic production zones. These findings indicated the company's production quality management did not adhere to the "Good Manufacturing Practice for Pharmaceuticals (2010 Revision)." Consequently, the Guangdong Provincial Drug Administration has been instructed to revoke the company's relevant GMP certificates and initiate further investigation and action.