China NMPA Drug Inspection - Anhui Taiyuan Traditional Chinese Medicine Pieces Co., Ltd. - Achyranthes bidentata

The "Jiangsu Province 2018 Issue 2 Drug Quality Bulletin," released by the National Medical Products Administration (NMPA) on May 14, 2018, details findings from drug quality inspections conducted leading up to this date. The inspections identified significant non-compliance across numerous pharmaceutical products and traditional Chinese medicine (TCM) pieces from various manufacturers, including Huazhong Pharmaceutical Co., Ltd., Taihua Natural Biopharmaceutical Co., Ltd., and several traditional Chinese medicine piece factories.

Key issues involved deviations from established regulatory frameworks such as the Chinese Pharmacopoeia (2010 and 2015 editions), National Drug Standards, and the Jiangsu Province Traditional Chinese Medicine Pieces Processing Standard. For chemical drugs, common violations included incorrect content determination (e.g., Vitamin B6 Tablets, Compound Danshen Tablets) and weight variation. In TCM pieces, widespread deficiencies were observed, encompassing non-conforming physical properties or appearance, incorrect moisture levels, issues with microscopic identification, excessive heavy metals (e.g., Honeysuckle), and sulfur dioxide residues (e.g., Achyranthes bidentata). Other specific problems included failures in extractives and total ash content for various herbs.

The identified violations necessitate prompt regulatory intervention. Manufacturers are required to investigate the root causes of these quality issues, implement comprehensive corrective and preventive actions, and potentially recall non-compliant batches to ensure public safety. Notably, several manufacturers disputed the findings, indicating some batches were "not produced by this company," which highlights challenges in supply chain accountability.