China NMPA Inspection - Zhengzhou Guanqiao Dental Prosthetics Co., Ltd. - December 13, 2018

An unannounced compliance inspection of Zhengzhou Guanqiao Dental Prosthetics Co., Ltd. was conducted on November 8, 2018, focusing on their manufacturing of customized removable dentures. The inspection, governed by the 'Good Manufacturing Practice for Medical Devices' and its specific 'Appendix for Customized Dentures,' revealed significant operational issues. Inspectors found the facility in a complete state of shutdown, lacking essential testing equipment, possessing only minimal production equipment, and having no finished products in storage. Furthermore, there were no management, production, or inspection personnel present, indicating a comprehensive cessation of activities. It was noted that the company had previously initiated a production suspension, with an application submitted on January 20, 2018, and officially publicized by the local regulatory authority on September 3, 2018, prior to this inspection. As a direct consequence, Zhengzhou Guanqiao Dental Prosthetics Co., Ltd. is prohibited from resuming any production operations. To regain authorization, the company must undergo and successfully pass a comprehensive re-inspection by the Henan Provincial Drug Administration, demonstrating full adherence to all applicable regulatory standards and good manufacturing practices.