China NMPA Drug Inspection - Wuhan Hanxinrui Pharmaceutical Co., Ltd. - Huoxiang Zhengqi Water

The Xinjiang Uygur Autonomous Region Drug Administration published an announcement on December 27, 2019, detailing the results of its 2019 Drug Quality Supervision and Sampling Work Plan. This regional initiative involved comprehensive inspections of drugs produced, distributed, and used by various entities, covering five main categories including chemical drugs and traditional Chinese medicine.

During the inspections, three batches of traditional Chinese medicine were found to be non-compliant with quality standards. The implicated manufacturers included Hubei Tongdetang Pharmaceutical Co., Ltd. (Naoxinshu Oral Solution), Wuhan Hanxinrui Pharmaceutical Co., Ltd. (Huoxiang Zhengqi Water), and Guangxi Bangqi Pharmaceutical Group Co., Ltd. (Huoxiang Zhengqi Mixture). These products were sampled from distribution and use units such as Kashi Jiuzhou Pharmacy, Kashi Huishengtang Pharmaceutical Chain Co., Ltd., and Xinjiang Kaixin Pharmaceutical Co., Ltd.

The primary violation identified for all three products was "Fill Volume," indicating the content did not meet specified quantities. The inspections were based on regulatory frameworks including the Chinese Pharmacopoeia 2015 Edition, Part I, and relevant National Drug Standards. Notably, the non-compliance for these specific samples was attributed as "not due to manufacturer reasons," suggesting potential issues during distribution or storage at the sampled units rather than initial production.

In response, the Xinjiang Uygur Autonomous Region Drug Administration has mandated that local market supervision departments investigate and take appropriate enforcement actions against the non-compliant products and all relevant production, distribution, and use units, ensuring adherence to laws and regulations.