China NMPA Drug Inspection - Sichuan Tianyun Minkang Traditional Chinese Medicine Pieces Co., Ltd. - Lotus seed heart

The Sichuan Provincial Drug Administration published a bulletin on August 16, 2019, detailing the outcomes of its 2019 drug sampling inspection program. These inspections, carried out across drug production, distribution, and use facilities throughout Sichuan Province, uncovered 23 batches of non-compliant drugs. Manufacturers identified in the violations include Jingfukang Pharmaceutical Group, Sichuan Wuzhi Traditional Chinese Medicine, Sichuan Kangquantang, and Sichuan Tuojiangyuan Pharmaceutical Co., Ltd., among others. The primary issues, assessed against the Chinese Pharmacopoeia 2015 Edition Part I, largely revolved around failures in content determination, indicating discrepancies in active ingredient quantities for various products like Shenling Baizhu Powder and Epimedium. Additional violations included unacceptable levels of extractives, erroneous drug identification through microscopic analysis or thin-layer chromatography, and excessive moisture or total ash content. In response, the regulatory authorities have initiated enforcement actions. The implicated companies are required to halt sales and use of the affected products, implement recalls, thoroughly investigate the underlying causes of non-compliance, and undertake comprehensive corrective measures to resolve the identified quality deficiencies.