China NMPA Drug Inspection - Guangxi Yulin Tailong Traditional Chinese Medicine Pieces Co., Ltd. - Bupleurum (Northern Bupleurum)

On June 8, 2021, the National Medical Products Administration (NMPA) released Announcement No. 36, detailing that 16 batches of drugs from 14 pharmaceutical companies were found to be substandard. High-profile companies cited include Hebei Jiuzheng Pharmaceutical Co., Ltd., Shandong Boshan Pharmaceutical Co., Ltd., and Shanxi Tianzhi Pharmaceutical Co., Ltd. The inspections, conducted by various provincial institutes for food and drug control, identified several quality failures across a range of products, including creams, capsules, and traditional Chinese medicine pieces. The primary violations involved microbial limits, which indicate potential contamination; fill volume and weight uniformity, which ensure accurate dosing; and content determination, reflecting incorrect levels of active ingredients. Other issues included excessive moisture, improper physical appearance, and the presence of impurities in herbal products. These findings were measured against the standards established in the Pharmacopoeia of the People's Republic of China. Under the framework of the Drug Administration Law, the NMPA has ordered the involved companies to implement immediate risk control measures, including the suspension of sales and the recall of non-compliant products. Regulatory authorities are also required to investigate the sources of these failures, ensure the enterprises implement effective corrective actions, and publicly disclose the results of the investigations into the production and sale of substandard drugs.