China NMPA Drug Inspection - Hebei Union Pharmaceutical CO., LTD. - Asarum

The Shaanxi Provincial Food and Drug Administration issued a Drug Quality Announcement on April 25, 2017, detailing findings from its 2016 provincial drug sampling inspection plan. This regulatory initiative aimed to enhance drug supervision and ensure public medication safety. Out of 669 batches of drugs sampled across the province, 20 batches were found to be substandard, resulting in a pass rate of 97.01%. A significant concern was that 12 of these non-compliant batches originated from non-labeled manufacturers.

Multiple pharmaceutical companies and traditional Chinese medicine pieces factories were implicated, including Zhengzhou Ruilong Pharmaceutical, Harbin Dongfang Pharmaceutical, Jilin Kuahai Biochemical Pharmaceutical Manufacturing, and Anhui Bozhou Sanzhen Traditional Chinese Medicine Pieces Co., Ltd. The main issues identified included failures in critical quality attributes such as identification, content determination, extractives, appearance, characteristics, and general inspection parameters. These violations were assessed against established regulatory frameworks, including the Chinese Pharmacopoeia (2010 and 2015 Editions), National Drug Standards, and Shaanxi Provincial Standards for Traditional Chinese Medicine Pieces.

In response to these findings, the relevant municipal and district food and drug administration departments are mandated to investigate and handle the involved entities in accordance with applicable laws and regulations, ensuring corrective actions are implemented to address the quality deficiencies.