China NMPA Drug Inspection - Henan Qianfang Pharmaceutical Co., Ltd. - Clematis

On August 28, 2020, the Henan Provincial Drug Administration published its third announcement of 2020 regarding seven batches of substandard drugs discovered during annual sampling inspections across production and distribution channels. The inspections identified non-compliant products from manufacturers including Henan Qianfang Pharmaceutical Co., Ltd., Wugang Hongkang Pharmaceutical Co., Ltd., and Anguo Changda Traditional Chinese Medicine Pieces Co., Ltd. One batch labeled as Anhui Meiyu Traditional Chinese Medicine Pieces Co., Ltd. was also flagged, though the company denied manufacturing it.

The violations primarily involved failures to meet standards set by the Chinese Pharmacopoeia (2015 Edition, Part I). Specific quality issues included failed property and identification tests, excessive sulfur dioxide residues, high levels of impurities and total ash, and inadequate content determination for active ingredients like berberine. In response to these findings, the regulatory authority has ordered involved entities to immediately suspend the sale and use of affected products and initiate mandatory recalls. Furthermore, the companies must conduct thorough investigations into the root causes of these quality failures and implement comprehensive rectification measures to ensure future compliance and protect public health.