China NMPA Drug Inspection - Chongqing Green Source Pharmaceutical Co., Ltd. - Elsholtzia

On December 25, 2020, the Chongqing Municipal Drug Administration published results from a quality supervision sampling inspection that identified seven batches of non-compliant drugs. The investigation involved six companies: Chongqing Sanlitang Traditional Chinese Medicine Pharmaceutical Co., Ltd., Southwest Pharmaceutical Co., Ltd., Chongqing Shangyao Huiyuan Pharmaceutical Co., Ltd., Chongqing Bolin Pharmaceutical Co., Ltd. (now Chongqing Ximei Pharmaceutical), Chongqing Lvseyuan Pharmaceutical Co., Ltd., and Chongqing Tianbao Pharmaceutical Co., Ltd. Main violations included failures in identification tests, incorrect physical properties, insufficient active content levels, and the presence of unauthorized related substances. These failures affected various traditional Chinese medicine decoction pieces, such as processed licorice root and Artemisia argyi, as well as Penicillin V Potassium tablets. The inspections were conducted under the regulatory framework of the Chinese Pharmacopoeia (2015 Edition) and local Chongqing pharmaceutical processing standards. To ensure public safety, the administration has ordered immediate regulatory actions, including the sealing and seizing of existing stock, the suspension of all sales, and the initiation of product recalls for the affected batches. Additionally, the bureau has launched formal investigations into the manufacturers to pursue further legal action and ensure compliance with drug safety regulations.