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

On December 29, 2017, the State Administration for Market Regulation (NMPA) announced findings from inspections revealing 38 batches of unqualified Traditional Chinese Medicine (TCM) decoction pieces from 29 enterprises. Inspections, led by institutions including the China National Institutes for Food and Drug Control, identified various quality issues. Violations included substandard appearance and identification for 13 batches of Bletilla striata, produced by companies such as Beijing Bencao Fangyuan Pharmaceutical Co., Ltd. Additionally, 23 batches of Amomum villosum, from companies including Anhui Yiyuantang Traditional Chinese Medicine Pieces Technology Co., Ltd., displayed substandard appearance and content determination. Other products like Codonopsis pilosula and Eupolyphaga sinensis also showed appearance deficiencies. In response, provincial food and drug administrations implemented control measures, seizing and sealing substandard products. Affected companies were ordered to suspend sales, recall products, and undertake rectifications. The NMPA directed provincial authorities to investigate these breaches under Articles 73, 74, and 75 of the "Drug Administration Law of the People's Republic of China." Public disclosure of investigation outcomes for the involved entities was mandated within three months, with provisions for severe penalties against manufacturers if product authenticity objections are disproven. This action underscores the NMPA's commitment to upholding drug quality and ensuring public health.