China NMPA Drug Inspection - Wuhan Beishen Pharmaceutical Co., Ltd. - Isatis root granules

On December 27, 2021, the Hubei Provincial Drug Administration published Issue 3 of its 2021 Quality Bulletin, reporting that 33 batches of drugs failed to meet national quality standards. The inspection covered various production, distribution, and healthcare units across the province. Involved companies include Hubei Shenlongyuan Pharmaceutical Co., Ltd., Hubei Phoenix Baiyunshan Pharmaceutical, and Beijing Tongrentang (Bozhou) Pharmaceutical Co., Ltd., among others. Main violations included failures in appearance, microscopic identification, and incorrect levels of active ingredients. Several traditional Chinese medicine products exceeded limits for ash content and impurities, while some manufacturers were found operating with expired licenses. Critically, one product, 'Baicao Jiangtang,' was identified as counterfeit due to the presence of undeclared chemical additives. These evaluations were conducted under the regulatory framework of the Chinese Pharmacopoeia (2015 and 2020 editions) and Hubei provincial standards for medical preparations. Required regulatory actions include the immediate sealing, seizure, and recall of non-compliant products. The administration has also ordered thorough investigations and administrative penalties for the responsible entities. For cases involving counterfeit goods or untraceable sources, the matter will be referred to public security organs for criminal prosecution to ensure public medication safety.