China NMPA Drug Inspection - Anhui Pujian Traditional Chinese Medicine Pieces Co., Ltd. - Codonopsis pilosula slices

On May 13, 2022, the Anhui Provincial Drug Administration published Bulletin Issue 5, identifying 18 batches of traditional Chinese medicine (TCM) products from 15 pharmaceutical companies that failed quality standards. Key companies cited include Anhui Tonghuatang Traditional Chinese Medicine Pieces Technology Co., Ltd., Anhui People's Traditional Chinese Medicine Pieces Co., Ltd., and Bozhou Guangyuantang Traditional Chinese Medicine Pieces Co., Ltd., among others. Inspections conducted by seven regional testing centers revealed several violations. The most frequent issues were related to product appearance, but more critical technical failures were also noted, including excessive moisture content, improper ash levels, and inadequate extractives. Specific products like Epimedium failed testing for active chemical content (total flavonoids and icariin), while others like Gentian failed across multiple categories including moisture and content determination. These findings are governed by the "Drug Administration Law of the People's Republic of China." Consequently, the regulatory body has ordered immediate risk control measures, requiring the involved enterprises to suspend all sales and usage of the affected batches and initiate product recalls. The companies must also conduct thorough investigations into the causes of these failures and implement effective rectification plans. Furthermore, local drug regulatory departments are tasked with investigating potential illegal activities regarding the production of substandard drugs, with the results slated for public disclosure.