China NMPA Drug Inspection - Shandong Haofu Pharmaceutical Group Co., Ltd. - Coronary Nerve Tablets (Plain Tablets)

On June 20, 2022, the National Medical Products Administration (NMPA) released Announcement No. 27 of 2022, detailing quality failures in 10 batches of pharmaceutical products. The manufacturers involved include Guangxi Jin Sangzi Pharmaceutical, Fuyuan Pharmaceutical, Guangxi Kangshiyuan Pharmaceutical, Jiangxi Shangao Pharmaceutical, Shandong Haofu Pharmaceutical Group, Sichuan Fengchun Pharmaceutical, Tibet Ganlu Tibetan Medicine, Bozhou Cijitang Traditional Chinese Medicine Pieces, and Beihai Nengxin Traditional Chinese Medicine. The inspections, conducted by various provincial testing institutions, identified several critical non-compliance issues. Key violations included incorrect pH values in topical gels, insufficient fill volumes in syrups, and identification failures in pediatric granules and capsules. Other issues noted were weight variations in tablets, substandard active ingredient content in granules, and appearance discrepancies in traditional medicinal herbs. These quality defects suggest potential issues in manufacturing processes, species identification, or storage conditions. Under the regulatory framework of the Drug Administration Law of the People's Republic of China, the NMPA has mandated immediate actions. The cited companies must implement risk control measures, including the suspension of sales and use, and the initiation of drug recalls. Furthermore, the enterprises are required to investigate the root causes of these failures and implement effective rectification measures. Provincial authorities have been directed to investigate these suspected illegal activities and publicly disclose the findings to ensure drug safety and industry accountability.