China NMPA Drug Inspection - Hebei Union Pharmaceutical CO., LTD. - Rehmannia

The National Medical Products Administration (NMPA) released an announcement on May 8, 2019, detailing significant quality control issues across 23 batches of drugs from eight different manufacturers. Comprehensive testing by various provincial drug control institutes revealed multiple instances of non-compliance. Noteworthy violations included the detection of "visible foreign matter" in paclitaxel injections produced by companies such as Shanxi Zhendong Taisheng Pharmaceutical Co., Ltd. and Harbin Pharmaceutical Group Biotechnology Co., Ltd. Additionally, Nanjing Baijingyu Pharmaceutical Co., Ltd. faced issues with "particle size" in 16 batches of chlortetracycline hydrochloride eye ointment. Other companies, including Hebei Kangyiqiang Pharmaceutical Co., Ltd. and Xinjiang Bencaotang Pharmaceutical Co., Ltd., were cited for discrepancies in "content determination," "acid-insoluble ash," and "total ash" for Rehmannia glutinosa, while peppermint from Ningxia Northwest Medicinal Materials Technology Co., Ltd. failed on "appearance" standards. The NMPA has mandated that the implicated enterprises immediately suspend sales, recall affected products, thoroughly investigate the root causes of these failures, and implement robust corrective measures. Furthermore, provincial drug regulatory authorities are required to investigate these illegal activities under Articles 73, 74, and 75 of the *Drug Administration Law of the People's Republic of China*, with findings and resolutions to be publicly disclosed within three months.