China NMPA Drug Inspection - Chengdu Lier Pharmaceutical Co., Ltd. - Amomum villosum

The State Administration for Market Regulation (now NMPA) issued an announcement on December 29, 2017, detailing findings from drug testing institutions, including the China National Institutes for Food and Drug Control. The announcement identified 38 batches of Traditional Chinese Medicine (TCM) decoction pieces, produced by 29 enterprises such as Anhui Yiyuantang Traditional Chinese Medicine Pieces Technology Co., Ltd., Beijing Bencao Fangyuan Pharmaceutical Co., Ltd., and Anguo Changda Traditional Chinese Medicine Pieces Co., Ltd., as substandard. Key violations involved product quality issues, specifically relating to appearance, identification, properties, and content determination for products like Bletilla striata, Amomum villosum, Codonopsis pilosula, and Eupolyphaga sinensis. These findings were assessed against the "Pharmacopoeia of the People's Republic of China" 2015 Edition and relevant provincial processing specifications. In response, provincial food and drug administrations were mandated to implement control measures including product sealing, seizure, sales suspension, recalls, and rectification. The State Food and Drug Administration required further investigation into these illegal acts under Articles 73, 74, and 75 of the "Drug Administration Law of the People's Republic of China," with public disclosure of handling results for the implicated companies within three months.