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

The Gansu Provincial Food and Drug Administration, on August 1, 2018, announced findings from targeted supervision and sampling inspections of Traditional Chinese Medicine (TCM) decoction pieces. These inspections addressed persistent quality concerns, including adulteration, counterfeiting, and improper processing methods like sulfur fumigation. Twenty-seven batches from various manufacturers and suppliers, such as Zhangye Jinsheng TCM Decoction Pieces Co., Ltd., Baoji Hanfang Traditional Chinese Medicine Pieces Co., Ltd., and Sichuan Yihe Pharmaceutical Co., Ltd., were found non-compliant. Key violations included excessive sulfur dioxide residue, failure to meet content specifications, incorrect appearance or identification, and unacceptable levels of impurities, total ash, acid-insoluble ash, or extractives, indicating significant quality and purity deficiencies. The regulatory framework for these inspections was the "Drug Administration Law of the People's Republic of China" and its implementing regulations, with compliance assessed against the Chinese Pharmacopoeia (2010 and 2015 editions). Required actions included immediate control measures like sealing and seizure of non-compliant products, mandates for enterprises to suspend sales and rectify issues, and instructions for local food and drug administration departments to investigate and prosecute illegal activities under Articles 73, 74, and 75 of the Drug Administration Law, with public announcements of results within three months.