China NMPA Drug Inspection - Hainan Shounanshan Ginseng Industry Co., Ltd. - Angelica pubescens

In an announcement issued on August 3, 2018 (NMPA Announcement No. 69 of 2018), the National Medical Products Administration (NMPA) reported that 11 batches of drugs from seven companies, including Anyang Lude Pharmaceutical Co., Ltd., were found to be non-compliant. The findings, based on testing by provincial institutes, revealed significant quality control issues.Specifically, six batches of Angelica pubescens from six companies, including Inner Mongolia Muxin Pharmaceutical Co., Ltd., Tianma (Anhui) Guoyao Technology Co., Ltd., Hunan Songlingtang Traditional Chinese Medicine Pieces Co., Ltd., Hunan Honghua Traditional Chinese Medicine Pieces Co., Ltd., and Hainan Shounanshan Ginseng Industry Co., Ltd., failed due to excessive sulfur dioxide residue and incorrect content determination. Additionally, five batches of cold and fever-reducing granules produced by Anyang Lude Pharmaceutical Co., Ltd. were substandard regarding moisture content and fill weight variation, indicating potential issues with stability and accurate dosing.The regulatory framework for these actions stems from the *Drug Administration Law of the People's Republic of China*. As a result, immediate control measures were implemented, including sealing and seizing the affected drugs, mandating product recalls, and requiring companies to suspend sales and use, and initiate rectification. Provincial drug regulatory authorities are tasked with investigating these companies for illegal activities related to producing and selling substandard drugs. These investigations must conclude within three months, with findings made public, emphasizing accountability and consumer safety.