China NMPA Drug Inspection - Xinjiang Enze Traditional Chinese Medicine Pieces Co., Ltd. - Amomum villosum

On December 29, 2017, China's State Administration for Market Regulation (NMPA) issued an announcement detailing significant findings from drug inspections. The regulatory action stemmed from tests conducted by multiple drug testing institutions, including the China National Institutes for Food and Drug Control. The inspections identified 38 batches of traditional Chinese medicine decoction pieces, produced by 29 different enterprises, as substandard.

Key companies implicated include Anhui Yiyuantang Traditional Chinese Medicine Decoction Pieces Technology Co., Ltd., Beijing Bencao Fangyuan Pharmaceutical Co., Ltd., and Anguo Changda Traditional Chinese Medicine Pieces Co., Ltd., among others. The primary violations involved critical quality parameters. For instance, 13 batches of Bletilla striata failed appearance and identification tests, while 23 batches of Amomum villosum were substandard in appearance and content determination, specifically for Bornyl Acetate. Additionally, single batches of Codonopsis pilosula and Eupolyphaga sinensis exhibited appearance deficiencies. These findings violated standards set by the 'Pharmacopoeia of the People's Republic of China' (2015 Edition) and provincial processing specifications.

In response, provincial food and drug administration departments initiated control measures, including product sealing and seizure. The affected enterprises were mandated to cease sales and usage, recall the substandard products, and implement corrective actions. Furthermore, the NMPA directed provincial authorities to investigate these illegal acts in accordance with Articles 73, 74, and 75 of the 'Drug Administration Law of the People's Republic of China,' requiring public disclosure of handling results within three months and timely reporting.