China NMPA Drug Inspection - Henan Jishi Pharmaceutical Co., Ltd. - Sanhuang tablets

On June 20, 2023, China’s National Medical Products Administration (NMPA) released Announcement No. 26 of 2023, identifying 15 batches of pharmaceutical products that failed to meet national quality standards. High-profile companies cited in the report include Xiuzheng Pharmaceutical Group Co., Ltd., Xi'an Gaoke Shaanxi Jinfang Pharmaceutical Co., Ltd., and Sichuan Meida Kanghua Kang Pharmaceutical Co., Ltd., among others.

Testing conducted by various municipal and provincial institutes revealed several critical quality issues. Key violations included the presence of visible foreign matter in injections, excessive microbial limits in Fukang tablets, and incorrect potency levels in ursodeoxycholic acid and Sanhuang tablets. Additionally, several batches of traditional Chinese medicine components were found to have non-compliant moisture and ash content levels.

Operating under the regulatory framework of the Drug Administration Law of the People's Republic of China, the NMPA has mandated immediate remedial steps. The affected companies must implement risk control measures, which include suspending the sale and use of the specific batches and initiating product recalls. Furthermore, the companies are required to investigate the root causes of these failures and implement effective rectification plans. Regional regulatory authorities have been directed to investigate any suspected illegal activities and publicly disclose their findings to ensure transparency and safeguard public health.