China NMPA Drug Inspection - Shanxi Zhendong Authentic Medicinal Herbs Development Co., Ltd. - Polygala tenuifolia

The Shaanxi Provincial Drug Administration issued Bulletin No. 72 on November 1, 2021, detailing the results of its third round of drug sampling inspections for the year. The report identifies four non-compliant batches of traditional Chinese medicine products manufactured by Anhui Baishuitang Traditional Chinese Medicine Pieces Co., Ltd., Anhui Jinfurong Traditional Chinese Medicine Pieces Co., Ltd., Bozhou Yonggang Pharmaceutical Factory Co., Ltd., and Shanxi Zhendong Authentic Medicinal Herbs Development Co., Ltd. The inspections, conducted in late 2021, evaluated products against the standards of the Chinese Pharmacopoeia 2015 Edition (Part I). Key quality issues discovered during testing included failures in physical appearance, incorrect concentrations of active ingredients (content determination), and improper levels of soluble substances (extractives). Specifically, the findings affected batches of Fried Hawthorn, Polygala, and Processed Aconitum carmichaelii found at various hospitals and industrial pharmacies. In response, Shaanxi regulatory authorities have implemented immediate control measures and initiated formal investigations into the manufacturers and distributors involved. These entities are required to comply with ongoing legal proceedings and administrative handling to ensure public medication safety and adherence to provincial drug regulations.