China NMPA Drug Inspection - Anhui Xiehecheng Pharmaceutical Pieces Co., Ltd. - Ume

The Henan Provincial Drug Administration issued an announcement on September 21, 2019, detailing findings of seven batches of substandard drugs from six manufacturers. Companies implicated include Anhui Yaozhiyuan Traditional Chinese Medicine Pieces Co., Ltd., Anhui Xiehecheng Pharmaceutical Pieces Co., Ltd., Anhui Bozhou Sanzhen Traditional Chinese Medicine Pieces Co., Ltd., Guizhou Bailing Enterprise Group Zhengxin Pharmaceutical Co., Ltd., Bozhou Changsheng Traditional Chinese Medicine Pieces Co., Ltd., and Maoming Junbang Traditional Chinese Medicine Pieces Co., Ltd. The main issues identified were quality deficiencies, with several traditional Chinese medicine products like Prunus mume, Evodia rutaecarpa, Sangjisheng, and Zaojiaoci failing appearance tests. Additionally, Norfloxacin capsules were found non-compliant due to a failed dissolution rate. These inspections were conducted under the regulatory framework of the Chinese Pharmacopoeia (2010 and 2015 editions) and other approved testing methods. As a result, the Administration mandated immediate risk control actions, including sealing, seizing, and suspending sales of the affected drug batches. Furthermore, regulatory departments were instructed to investigate and penalize the responsible units to ensure adherence to quality standards.