China NMPA Drug Inspection - Qianjiang City Traditional Chinese Medicine Hospital - Fritillaria thunbergii

The State Food and Drug Administration (now NMPA) issued an announcement detailing the investigation and handling of unqualified Traditional Chinese Medicine (TCM) materials, specifically "Zhejiang Fritillaria," affecting two user units in Hubei province.Ezhou Central Hospital was inspected, with sampling occurring on July 21, 2016, and an investigation initiated on November 18, 2016, closing on December 7, 2016. The hospital was found to have purchased and used Zhejiang Fritillaria (batch 150501, labeled manufacturer Anhui People's Traditional Chinese Medicine Pieces Co., Ltd.) with sulfur dioxide residue exceeding regulatory limits. This violated Article 49 of the "Drug Administration Law of the People's Republic of China." As a result, the Ezhou Municipal Food and Drug Administration confiscated 691.2 yuan in illegal profit and issued a fine of 1313.3 yuan, totaling 2004.5 yuan.Similarly, Xianning Municipal Traditional Chinese Medicine Hospital faced an investigation following sampling on June 22, 2016, with the case closing on January 18, 2017. They purchased and used Zhejiang Fritillaria (batch 151003, labeled manufacturer Shaanxi Longli Pharmaceutical Co., Ltd.) also containing excessive sulfur dioxide. Furthermore, essential documentation like sales and delivery lists and authorization letters were not legitimately issued by the labeled manufacturer, indicating potential supply chain integrity issues. Based on the same "Drug Administration Law" and Hubei provincial regulations, the Xianning Municipal Food and Drug Administration confiscated 8019 yuan in illegal gains and imposed a fine of 12960 yuan, for a total of 20979 yuan. The case also recommended transferring the involved sales representative to public security for further investigation into the source of the substandard materials.