China NMPA Inspection - Hefei Dunke Biomedical Co., Ltd. - January 25, 2019

Hefei Dunke Biomedical Co., Ltd. underwent an unannounced inspection by the National Medical Products Administration Audit and Inspection Center from August 21-23, 2018. The inspection, conducted as part of the National Pharmaceutical Enterprise Annual Inspection Plan, identified multiple serious violations of the "Good Supply Practice for Pharmaceutical Products" regulatory framework. Key issues included inaccurate pharmaceutical sales invoicing, with VAT invoices for drug sales incorrectly listing other substances like "Cordyceps sinensis" and "Macaca," indicating a lack of consistency between invoices, accounts, goods, and payments. The company also failed to ensure its quality management department responsibilities were performed by internal personnel, as an external pharmacist temporarily assumed the role. Further deficiencies involved a substandard automatic temperature and humidity monitoring system in the warehouse, the absence of a required computer system for full drug traceability and comprehensive quality control, and a failure to store drugs at their specified packaging temperatures. In response to these serious non-compliances, the Anhui Provincial Drug Administration has revoked Hefei Dunke Biomedical Co., Ltd.'s "Good Supply Practice for Pharmaceutical Products" certification. Additionally, the company is currently under investigation for suspected illegal and irregular business practices.