China NMPA Drug Inspection - Yongzhou Yongdian Traditional Chinese Medicine Pieces Co., Ltd. - Lightly fermented black soybeans

The National Medical Products Administration (NMPA) of China issued Announcement No. 85 of 2019 on November 26, 2019, detailing significant drug quality issues discovered across 57 batches produced by 40 companies. Testing by various drug inspection institutions revealed multiple non-compliant drugs, ranging from chemical preparations to traditional Chinese medicine components. Prominent violations included Kangpu Pharmaceutical Co., Ltd. and Jiangsu Jurong Pharmaceutical Group Co., Ltd. for issues with product appearance. Shanxi Guorun Pharmaceutical Co., Ltd.'s Acetylcysteine Inhalation Solution failed due to hydrogen sulfide and related substances, while Guangxi Wuzhou Sanjian Pharmaceutical Co., Ltd.'s Cold and Cough Syrup had content determination failures. Numerous traditional Chinese medicine companies, including Bozhou Zhongqiang Traditional Chinese Medicine Pieces Co., Ltd. and Xinjiang Bencaotang Pharmaceutical Co., Ltd., faced non-compliance for substances like Psoralea corylifolia, Pinellia ternata, and Dragon's Blood, with issues covering appearance, identification, extractives, moisture content, and in some cases, the detection of unauthorized substances like 808 scarlet and rosin acid. Operating under the "Drug Administration Law of the People's Republic of China" and national pharmacopoeia standards, the NMPA mandated immediate risk control measures, including product sales suspension, usage halt, and recalls. All implicated companies are required to investigate the root causes of non-compliance and implement effective rectification. Provincial drug regulatory authorities were instructed to conduct thorough investigations into these violations within three months, publicize findings, and ensure inter-agency cooperation in tracing and resolving these critical quality deviations.