China NMPA Inspection - Hunan Ping An Medical Device Technology Co., Ltd. - April 26, 2016

An important report published on April 26, 2016, by the National Medical Products Administration (NMPA) detailed the findings of an unannounced inspection of Hunan Ping An Medical Device Technology Co., Ltd. The inspection revealed significant deviations from regulatory standards, specifically citing that the company's operations did not adhere to the relevant requirements of the Good Manufacturing Practice for Medical Devices. This indicates that the company's processes for designing, manufacturing, packaging, labeling, storing, and distributing medical devices did not meet the established quality standards. Furthermore, the inspection identified notable deficiencies within Hunan Ping An Medical Device Technology Co., Ltd.'s quality management system. These systemic shortcomings suggest issues in the company's organizational structure, responsibilities, procedures, processes, and resources for implementing quality management. As a result of these findings, the Hunan Provincial Food and Drug Administration, the regulatory authority overseeing the province, issued a directive to Hunan Ping An Medical Device Technology Co., Ltd. The company has been mandated to address and correct all identified deficiencies within a specified period to bring its operations into full compliance with the medical device manufacturing regulations.