China NMPA Drug Inspection - Zhangzhou Jushantang Pharmaceutical Co., Ltd. - Northern Sophora root

The Fujian Province Drug Quality Announcement (Issue 6, 2017, Total Issue 67), published on July 31, 2017, reports on supervision and sampling inspections conducted by provincial and municipal food and drug regulatory departments in Fujian, China. These inspections aimed to uphold public medication safety across drug production, distribution, and user units. The regulatory framework for these assessments was based on the "Drug Administration Law of the People's Republic of China" and various editions of the "Chinese Pharmacopoeia." Fifteen batches of drugs were identified as non-compliant with these established standards. Key manufacturers implicated in multiple non-compliances include Zhangzhou Jushantang Pharmaceutical Co., Ltd., Jiangxi Shunfutang Traditional Chinese Medicine Pharmaceutical Pieces Co., Ltd., and Zhangshu Qingren Traditional Chinese Medicine Slices Co., Ltd. The primary issues identified were unacceptable levels of "Sulfur Dioxide Residue" in several Traditional Chinese Medicine ingredients like Angelica sinensis, Moutan Cortex, and Yam Slices. Additional violations concerned product "Appearance," "Properties," and "Identification" (including microscopic identification and content determination) for items such as Sophora flavescens, Asarum sieboldii, Cicada Slough, Kudzu Root, and Madder. In response, regulatory departments are currently undertaking investigations and implementing appropriate legal actions for the non-compliant drugs and their respective units.