China NMPA Drug Inspection - Yichun Wujiashen Pharmaceutical Co., Ltd. - Northern Sophora Root Slices

The "Henan Province Drug (Packaging Material) Quality Announcement (Issue No. 38)," issued on December 30, 2015, details findings from supervision and sampling inspections conducted throughout 2015 by the Henan Provincial Food and Drug Administration. These inspections aimed to uphold public medication safety under the "Drug Administration Law of the People's Republic of China" and the "Chinese Pharmacopoeia 2010 Edition."The inspections identified numerous quality control failures across a broad spectrum of pharmaceutical and medical packaging companies, including Henan Qingshan Pharmaceutical Co., Ltd., Yuzhou Jingang Medical Materials Co., Ltd., Anhui Yiyuantang Traditional Chinese Medicine Slices Technology Co., Ltd., and Shijiazhuang Huapeng Pharmaceutical Co., Ltd., among others. Main violations encompassed issues such as substandard extractives, visible foreign matter in injectables, incorrect disintegration times for tablets, and failures in identification tests for various medications. Several cases of counterfeit drugs, including Compound Glycyrrhiza Tablets and Ketoconazole Lotion, falsely labeled with names like Guilin Nanfang Pharmaceutical Co., Ltd. and Xi'an Janssen Pharmaceutical Co., Ltd., were detected. Furthermore, adulteration was found in traditional products like donkey-hide gelatin, which contained bovine-hide source material. Medical packaging bottles also failed density and residue on ignition requirements.All local authorities are required to investigate and take appropriate action against the responsible parties in accordance with the regulatory framework.