China NMPA Drug Inspection - Hebei Union Pharmaceutical CO., LTD. - Bamboo Yellow

The Inner Mongolia Autonomous Region Food and Drug Administration announced on July 23, 2018, findings of non-compliance for three batches of drugs. Yan'an Pharmaceutical Co., Ltd.'s Kouyanqing Granules failed due to a difference in fill weight, indicating issues with content uniformity that could lead to inaccurate dosages and safety risks, likely stemming from unstable manufacturing processes. Separately, Hebei Quantai Pharmaceutical Co., Ltd.'s Tianzhuhuang and Anhui Puren Traditional Chinese Medicine Pieces Co., Ltd.'s Difengpi both failed appearance tests. These appearance failures suggest potential problems with raw material quality, manufacturing processes, or storage conditions, directly impacting drug quality.

Regulatory authorities promptly implemented control measures, including product sealing, seizure, suspension of sales and use, and mandatory recalls for rectification. The regulatory framework for these actions is derived from Articles 73, 74, and 75 of the "Drug Administration Law of the People's Republic of China," which address the production and sale of substandard drugs. Municipal-level food and drug supervision departments were instructed to investigate these companies for illegal activities, with each investigation and its resolution to be completed and publicly disclosed within three months of receiving the inspection report.