China NMPA Drug Inspection - Shaanxi Kangchao Kangjian Pharmaceutical Co., Ltd. - Prepared white aconite

The Shaanxi Provincial Drug Administration announced on November 25, 2019, the findings from its 9th drug quality inspection of 2019. This regulatory action aimed to strengthen drug supervision and ensure public medication safety across the province. The inspections identified seven batches of drugs from multiple manufacturers as non-compliant with established quality standards. Key companies implicated include Gansu Guocao Pharmaceutical Co., Ltd., Ningxian Kangshengyuan Pharmaceutical Co., Ltd., Yuncheng City Shennong Chinese Medicinal Materials Co., Ltd., Chengdu Jiankang Pharmaceutical Co., Ltd., Sichuan Qianfang Traditional Chinese Medicine Co., Ltd., and Shaanxi Kangchao Kangjian Pharmaceutical Co., Ltd. The primary violations involved failures in drug properties, extractives content, accurate content determination, and other general inspection criteria. These findings were benchmarked against regulatory frameworks such as the Chinese Pharmacopoeia and Ministry of Health Drug Standards. In response, relevant municipal drug regulatory departments have initiated necessary control measures, including investigations, in accordance with applicable laws and regulations. It was noted that some manufacturers disputed the origin of the non-compliant products attributed to them.