China NMPA Drug Inspection - Tonghua Jinkaiwei Pharmaceutical Co., Ltd. - Synovitis tablets

The National Medical Products Administration (NMPA) of China issued Announcement No. 60 of 2019 on August 27, 2019, publicizing that 11 batches of drugs from eight different pharmaceutical companies failed to meet established quality standards. Testing conducted by several drug inspection institutions, including the China National Institutes for Food and Drug Control, revealed various critical non-compliances. Specific issues identified include content uniformity and content determination for fluoxetine hydrochloride capsules from Suzhou Yushi Pharmaceutical Co., Ltd., and visible foreign matter in compound vitamin B injection by Hainan Pharmaceutical Factory Co., Ltd. Other significant violations encompassed microbial limits for synovitis tablets from Tonghua Jinkaiwei Pharmaceutical Co., Ltd. and Liushen capsules from Lei Yunshang Pharmaceutical Group Co., Ltd. Additionally, cold soft capsules from Henan Xueyinghua Pharmaceutical Co., Ltd. failed the disintegration time limit, while Shuanghuang Xiaoyan tablets from Guangxi Ritian Pharmaceutical Group Co., Ltd. and Guangxi Nanning Dezhi Pharmaceutical Co., Ltd. exhibited weight variation issues. Notably, Hunan Hengwei Pharmaceutical Co., Ltd.'s refined coronary heart disease tablets were found to contain Orange II, indicating a potential adulteration. In response, the NMPA, operating under the "Drug Administration Law of the People's Republic of China," has mandated immediate risk control measures. These include suspending sales, discontinuing use, and initiating recalls for all affected products. The implicated companies are required to thoroughly investigate the root causes of these non-compliances and implement robust corrective actions. Furthermore, provincial drug regulatory authorities are tasked with investigating these entities for illegal drug production and sales, with results to be publicized within three months of receiving inspection reports.