China NMPA Drug Inspection - Anhui Haoyuan Pharmaceutical Co., Ltd. - Atractylodes lancea

The Gansu Provincial Food and Drug Administration, on March 28, 2018, announced the findings from targeted supervision and sampling inspections conducted across the province on traditional Chinese medicine (TCM) decoction pieces. The inspections focused on products historically prone to non-compliance, adulteration, counterfeiting, or improper processing like dyeing, weight-increasing, or sulfur fumigation. As a result, 21 batches of TCM decoction pieces from various manufacturers were identified as substandard. Common violations included failures in properties, identification, content determination, and other inspection parameters such as impurities, total ash, acid-insoluble ash, and sulfur dioxide residues, indicating significant quality and purity deficiencies. The regulatory framework for these actions includes the "Drug Administration Law of the People's Republic of China" and its implementation regulations, with product evaluations based on the "Chinese Pharmacopoeia 2010" and "2015 Editions." Required actions include immediate control measures like sealing and seizing substandard products, mandates for sampled units to suspend sales, cease use, and rectify issues. Additionally, municipal food and drug administration departments must investigate and prosecute these illegal activities, publicly disclose handling results for responsible enterprises within three months, and report all relevant information to the Provincial Bureau to ensure drug quality and public safety.