China NMPA Drug Inspection - Shanxi Tongda Pharmaceutical Co., Ltd. - Atractylodes lancea

The Gansu Provincial Food and Drug Administration in China issued a drug quality announcement on August 1, 2018, detailing findings from targeted supervision and sampling inspections. These inspections focused on Traditional Chinese Medicine (TCM) decoction pieces, which have historically presented issues such as adulteration, counterfeiting, and improper processing like sulfur fumigation or weight-increasing practices. The regulatory body identified 27 batches of non-compliant TCM decoction pieces from multiple manufacturers and suppliers, including Zhangye Jinsheng TCM Decoction Pieces Co., Ltd., Baoji Hanfang Traditional Chinese Medicine Pieces Co., Ltd., and Sichuan Yihe Pharmaceutical Co., Ltd. Key violations encompassed excessive sulfur dioxide residue, discrepancies in active ingredient content, issues with the product's physical properties and identification, and unacceptable levels of impurities like total ash. These findings indicate significant quality, purity, and authenticity concerns. In accordance with the "Drug Administration Law of the People's Republic of China" and its implementing regulations, the administration mandated immediate control measures, including sealing and seizing affected products, suspending sales and use, and requiring companies to rectify issues. Local food and drug authorities were instructed to investigate and prosecute illegal activities related to substandard drugs, with public announcements of outcomes required within three months.