China NMPA Drug Inspection - Shaanxi Kangyu Pharmaceutical Co., Ltd. - Prepared white aconite

On October 30, 2020, the Shaanxi Provincial Drug Administration published the tenth issue of its 2020 Drug Quality Bulletin, detailing the results of recent provincial drug sampling inspections. The report identified three batches of non-compliant drugs from manufacturers including Shaanxi Kangyu Pharmaceutical Co., Ltd., Shaanxi Hantang Pharmaceutical Co., Ltd., and Bozhou Yuanguang Traditional Chinese Medicine Processing Plant. The specific violations involved failures in extractives testing for processed Aconitum carmichaelii, general inspection failures for Compound Danshen Tablets, and content determination issues for prepared licorice root. These inspections were conducted under the regulatory framework of the Chinese Pharmacopoeia (2015 Edition, Part I) and supplementary testing protocols authorized by the State Food and Drug Administration. Testing was performed by the Xianyang and Xi'an Municipal Institutes of Food and Drug Inspection. In response to these findings, the Shaanxi Provincial Drug Administration has instructed local municipal and county-level departments to seize the non-compliant products and initiate formal investigations into the involved entities. These actions are intended to ensure public medication safety and enforce compliance with national pharmaceutical standards through strict administrative handling and public disclosure of quality violations.