China NMPA Drug Inspection - Bozhou Haomen Traditional Chinese Medicine Pieces Co., Ltd. - ground beetle

On December 29, 2017, the China Food and Drug Administration (CFDA) announced significant quality control issues following the testing of 38 batches of traditional Chinese medicine (TCM) decoction pieces. Conducted by four national drug testing institutions, the inspections revealed substandard products from 29 enterprises, including Anhui Yiyuantang Traditional Chinese Medicine Decoction Pieces Technology Co., Ltd. and Beijing Bencao Fangyuan Pharmaceutical Co., Ltd. The primary violations involved critical TCM ingredients such as Bletilla striata, Amomum villosum, Codonopsis pilosula, and Eupolyphaga sinensis, which exhibited deficiencies in appearance, identification, and content determination. Under the "Drug Administration Law of the People's Republic of China" (Articles 73, 74, and 75), the CFDA mandated provincial food and drug administration departments to take immediate action. These actions included sealing and seizing non-compliant products, suspending sales, initiating recalls, and requiring rectification from the implicated companies. Furthermore, provincial authorities were instructed to thoroughly investigate the illegal acts, publicly disclose the investigation outcomes within three months, and report all findings promptly. The announcement also detailed a procedure for companies to contest product authenticity, which would lead to further investigation and potentially severe penalties for confirmed manufacturers.