China NMPA Drug Inspection - Jiangxi Sanyuan Pharmaceutical Co., Ltd. - Snake Gallbladder and Fritillaria Capsules

The Sichuan Provincial Food and Drug Administration issued a comprehensive drug quality announcement (Fifth Issue, 2018) on July 12, 2018, detailing the outcomes of supervisory sampling inspections. These inspections were carried out across various drug production, distribution, and use entities within Sichuan province, aiming to strengthen oversight and ensure the safe and effective use of pharmaceuticals. The regulatory framework for these activities included the National Drug Sampling Inspection Management Measures, Sichuan Provincial drug sampling work requirements, the Chinese Pharmacopoeia, and other relevant national and ministry drug standards. The announcement identified 23 batches of drugs that failed to meet established quality specifications. The violations were diverse, encompassing issues such as quantity differences, unsatisfactory physical or chemical properties (e.g., moisture, impurities, microbial limits, sulfur dioxide residues), and failures in active ingredient content determination or identification tests. Manufacturers and distributors from multiple regions were implicated. In response, local city and prefecture Food and Drug Administrations are mandated to investigate and prosecute the responsible parties in accordance with the Drug Administration Law and its implementing regulations. They are required to publicly disclose the results of these enforcement actions within three months and promptly report relevant information to the Provincial Administration, ensuring public health and safety.