China NMPA Drug Inspection - Sichuan Pharmaceutical Co., Ltd. - Xianmao

The Sichuan Provincial Drug Administration, in adherence to its 2019 Drug Sampling Inspection Work Plan, performed comprehensive quality inspections on various drug production, distribution, and use units. This initiative culminated in an announcement on September 10, 2019, identifying 19 batches of non-compliant drugs from multiple manufacturers, including Qinghai Chaidamu High-Tech Pharmaceutical, Neijiang Baishengtang Pharmaceutical, and Sichuan Tuojiangyuan Pharmaceutical, among others.The inspections, conducted against the stringent standards of the Chinese Pharmacopoeia (2015 Edition), uncovered a range of quality control deficiencies. These issues encompassed problems with drug appearance, moisture content, disintegration time, total ash and acid-insoluble ash levels, inaccurate identification, inconsistent extractive content, and deviations in the quantitative determination of active ingredients such as iron salt, atractylodes, coltone, curculigo glycoside, curculigo orchioides, and epimedium.In response, the regulatory authorities have issued clear directives to the affected companies. Required actions include the immediate suspension of sales and use of the identified non-compliant batches, comprehensive product recalls, thorough investigations into the root causes of these quality failures, and the implementation of robust and complete rectification measures to ensure future compliance and safeguard public health.