China NMPA Drug Inspection - Bozhou Xinghe Pharmaceutical Co., Ltd. - Bletilla striata

The Heilongjiang Provincial Food and Drug Administration announced on May 18, 2018, the discovery of ten batches of substandard Traditional Chinese Medicine (TCM) pieces following tests by various inspection institutes. The announcement pertains to products from multiple companies, including Hebei Jixintang Pharmaceutical Co., Ltd., Fujian Hengxin Pharmaceutical Co., Ltd., and several others from Hebei, Heilongjiang, Anhui, and Jilin provinces.

Key violations identified across the products included issues with content determination, visual appearance, product identification, and general inspection standards. Notably, some cases involved products with labeled manufacturers that either denied production, had ceased operations, or had their production licenses revoked, indicating significant challenges in product traceability and potential instances of fraudulent labeling. For example, a product labeled from Heilongjiang Hexiangchun Traditional Chinese Medicine Pieces Co., Ltd. was confirmed not to have been produced by that company.

Under the framework of the *Drug Administration Law of the People's Republic of China*, specific actions have been mandated. Food and drug administration departments where the samples originated have initiated control measures, including sealing and seizing the substandard batches, and requiring units to cease their sale and use. Furthermore, these departments are required to investigate and prosecute the illegal sale and use of these products, referring any suspected criminal cases to public security departments. The results of these enforcement actions must be publicly disclosed within three months, with reports submitted to the Provincial Bureau.