China NMPA Drug Inspection - Anguo City Juyitang Pharmaceutical Co., Ltd. - amber

The Shaanxi Provincial Food and Drug Administration (SFDA) released an announcement on May 16, 2018, detailing findings from its fifth drug quality inspection of 2018, with inspection activities preceding the May 10, 2018, announcement. This provincial-level initiative aimed to strengthen drug supervision and ensure public medication safety. The inspections identified five batches of non-compliant drugs from several manufacturers, including Bozhou Yonggang Pharmaceutical Pieces Factory Co., Ltd., Baoji Hanfang Traditional Chinese Medicine Pieces Co., Ltd., Hebei Quantai Pharmaceutical Co., Ltd., and Anguo Tongkang Pharmaceutical Co., Ltd. The main violations encompassed critical quality attributes such as properties, identification, general inspection parameters, extractives, and content determination. For instance, 'V Add skin (Jiapi)' failed extractives tests, while 'Cistanche deserticola' and 'Amber' showed non-compliance in properties. 'Mulberry Leaf' failed content determination, and 'Salt-processed Eucommia' and 'Amber' had issues with general inspection. The regulatory framework for these assessments primarily referenced the Chinese Pharmacopoeia (2015 Edition, Part I) and the Shaanxi Provincial Standards for Traditional Chinese Medicine Pieces (2008 Edition, Volume 1). In response, relevant municipal and district food and drug regulatory departments have implemented necessary control measures for the affected entities and initiated investigations in accordance with applicable laws and regulations.