China NMPA Drug Inspection - Anhui People"s Traditional Chinese Medicine Pieces Co., Ltd. - betel nut

The National Medical Products Administration (NMPA) of China issued Announcement No. 72 on August 10, 2018, revealing significant quality control issues in nine batches of drugs from seven pharmaceutical companies. Inspections conducted by various provincial institutes identified non-compliance across several products. Specifically, six batches of Areca Nut, manufactured by companies including Gansu Tasly Zhongtian Pharmaceutical Co., Ltd., Anhui Bozhou Qiancao Pharmaceutical Co., Ltd., Anhui Renmin Traditional Chinese Medicine Pieces Co., Ltd., Hainan Shounanshan Ginseng Industry Co., Ltd., and Hainan Guoruitang Traditional Chinese Medicine Pharmaceutical Co., Ltd., failed to meet standards due to excessive aflatoxin and moisture content. One batch of Qipi Pills from Shaanxi Ziguang Chenji Pharmaceutical Co., Ltd. was found non-compliant with content determination requirements, and two batches of Erythromycin Stearate Capsules from Jilin Hengxing Technology Pharmaceutical Co., Ltd. exhibited issues with moisture content and dissolution rate. These violations indicate a failure to adhere to the quality specifications outlined in the *Pharmacopoeia of the People's Republic of China 2015 Edition*. In response, regulatory authorities initiated control measures such as sealing, seizure, suspending sales and use, and recalling the affected products. The NMPA has mandated provincial drug regulatory authorities to investigate these companies for their illegal activities under Articles 73, 74, and 75 of the *Drug Administration Law of the People's Republic of China*, requiring completion and public disclosure of investigation results within three months.