China NMPA Drug Inspection - Bozhou Jingwan Traditional Chinese Medicine Pieces Factory, China - Pinellia ternata

The Shaanxi Provincial Food and Drug Administration (SFDA) issued an announcement on May 23, 2017, detailing findings from its 5th drug sampling inspection of 2017. These inspections, conducted by regulatory departments across Shaanxi Province, identified 22 batches of drugs from various manufacturers, including Bozhou Yonggang Pharmaceutical Pieces Co., Ltd. and Guizhou Jinyu Pharmaceutical Co., Ltd., that failed to meet quality standards. The main violations discovered across traditional Chinese medicine products and pharmaceutical packaging materials frequently involved discrepancies in fundamental quality parameters such as "properties," "identification," "content determination," and general "inspection" tests like total ash, residue on ignition, and dissolution. These non-compliances indicated failures to adhere to established quality specifications, primarily those outlined in the Chinese Pharmacopoeia (2010 and 2015 editions) and various national pharmaceutical packaging material standards. In response, relevant municipal and county food and drug regulatory departments have implemented necessary control measures for the implicated entities and are conducting investigations and enforcement actions in accordance with applicable laws and regulations to ensure public medication safety.