China NMPA Inspection - Xi'an Daidai Biomedical Engineering Co., Ltd. - October 30, 2018

Xi'an Daidai Biomedical Engineering Co., Ltd. was subject to an unannounced compliance inspection by the National Medical Products Administration (NMPA) on October 16, 2018. The inspection, conducted against the *Good Manufacturing Practice for Medical Devices* and its *Appendix for Sterile Medical Devices*, identified significant operational deficiencies. Inspectors found that the company had ceased all production activities on September 30, 2018, following a directive from its industrial park management to complete environmental treatment. During the inspection, there were no production personnel on duty, nor any signs of ongoing manufacturing. Critical operational records for production equipment, testing instruments, and process water preparation were only updated through the end of September. As a result, Xi'an Daidai Biomedical Engineering Co., Ltd. is prohibited from resuming production until it successfully passes a subsequent inspection by the Shaanxi Provincial Bureau, ensuring full compliance with regulatory standards.