China NMPA Drug Inspection - Shaanxi Duoyao Traditional Chinese Medicine Pieces Co., Ltd. - Traditional Chinese medicine decoction pieces (processed aconite, indigo naturalis)

On November 24, 2017, the State Administration for Market Regulation (formerly CFDA) announced that 14 batches of Traditional Chinese Medicine (TCM) decoction pieces, produced by 11 companies including Hainan Shounanshan Ginseng Industry Co., Ltd., Fujian Hengxin Pharmaceutical Co., Ltd., and Jiangxi Hongjie Traditional Chinese Medicine Pieces Co., Ltd., were found to be substandard. Tests conducted by the China National Institutes for Food and Drug Control identified issues with processed aconite and indigo naturalis. Key violations included deficiencies in content determination, general inspection, physical properties, and identification. Provincial food and drug administration departments promptly initiated control measures, such as sealing and seizing products, suspending sales, ordering recalls, and requiring corrective actions. The State Food and Drug Administration mandated provincial departments to investigate these illegal acts of producing and selling substandard drugs, referencing Articles 73, 74, and 75 of the 'Drug Administration Law of the People's Republic of China.' These departments were instructed to publicly disclose investigation results within three months, with provisions for companies to dispute product authenticity, triggering further investigation and potential severe penalties for confirmed manufacturers.