China NMPA Drug Inspection - Chengde Tianyuan Pharmaceutical Co., Ltd. - Gardenia and Honeysuckle Pills

On July 17, 2020, the Jiangxi Provincial Drug Administration published the results of its third 2020 drug supervision and sampling inspection. The report identified quality failures in six batches of pharmaceutical products from several manufacturers, including Shanghai Xudong Haipu Pharmaceutical Co., Ltd., Guangxi Jinye Pharmaceutical Co., Ltd., Hubei Ji'antang Pharmaceutical Co., Ltd., Chengde Tianyuan Pharmaceutical Co., Ltd., and Shandong Phoenix Pharmaceutical Co., Ltd. The inspections, conducted under the legal framework of the Drug Administration Law and the 2015 Chinese Pharmacopoeia, revealed significant quality control violations. Primary issues included the presence of visible foreign matter in injections, incorrect moisture levels, and substantial weight discrepancies in tablets and pills. Some samples also failed to meet the required standards for physical appearance. In response to these findings, the provincial administration has ordered immediate corrective actions, including the sealing, seizure, and suspension of sales for all non-compliant batches. Affected products must be recalled, and the regulatory body has initiated formal investigations into the manufacturers and sampling units to determine appropriate legal penalties and ensure public safety.