China NMPA Drug Inspection - Heilongjiang Linshi Shengtai Pharmaceutical Co., Ltd. - Coltsfoot

This announcement from the Heilongjiang Provincial Drug Administration, dated November 15, 2019, details findings regarding 11 batches of substandard traditional Chinese medicinal herbs and decoction pieces. Several companies were identified, including Mudanjiang Wanbing Chinese Medicinal Herbs Co., Ltd., Heilongjiang Xiangtai Chinese Medicinal Herbs Co., Ltd., Harbin Qigongtang Chinese Medicinal Herbs Co., Ltd., Heilongjiang Linshi Shengtai Pharmaceutical Co., Ltd., Harbin Yutai Pharmaceutical Co., Ltd., Anhui Yaozhiyuan TCM Decoction Pieces Co., Ltd., and Wuhai Weidekang TCM Decoction Pieces Co., Ltd. The primary issue involved the production and sale of substandard products, such as Potentilla chinensis, Ligustrum lucidum, Ziziphus jujuba seed, and Schisandra chinensis fruit. A significant violation confirmed for six of these batches was that they were "not produced by the labeled companies," indicating potential misrepresentation or illicit manufacturing. In response, regulatory authorities initiated immediate control measures, including sealing and seizing the affected batches and ordering sampled units to cease their sale and use. The Provincial Drug Administration also informed regulatory departments in other provinces about substandard products labeled as being from enterprises outside its jurisdiction. All levels of drug regulatory departments within the province were instructed to investigate and prosecute these illegal activities concerning the production, sale, and use of substandard Traditional Chinese Medicine decoction pieces, in accordance with the "Drug Administration Law of the People's Republic of China" and related regulations. This comprehensive action aims to uphold product quality and integrity within the pharmaceutical supply chain.