China NMPA Inspection - Mindray Bio-Medical Engineering Co., Ltd. - December 13, 2018

An unannounced inspection of Mindray Bio-Medical Electronics Co., Ltd. was conducted on November 8-9, 2018, focusing on their Hepatitis C Virus Antibody Assay Kit (Chemiluminescence Method) production. The inspection, based on the *Good Manufacturing Practice for Medical Devices* and its *Appendix for In Vitro Diagnostic Reagents*, uncovered several critical issues. Key findings included the company's failure to draft, review, approve, and issue the Management Representative's Job Description according to established document control procedures. Additionally, usage records for a chemiluminescence analyzer on November 5th were incomplete, not specifying the testing items. A notable concern was the lack of verification for the shelf life of opened biological materials, such as antigens and antibodies. Consequently, Mindray Bio-Medical Electronics Co., Ltd. has been mandated by the Sichuan Provincial Drug Administration to rectify these issues within a defined period. The company must also assess product safety risks and recall any products posing potential hazards, as per medical device recall regulations. Follow-up inspections will be conducted, and the rectification progress will be reported to the National Medical Products Administration.