China NMPA Inspection - Yunnan Chuxiong Prefecture Medical Equipment Co., Ltd. - October 30, 2018

Yunnan Chuxiong Medical Device Co., Ltd. was subject to an unannounced compliance inspection on October 16, 2018. The inspection, conducted by the National Medical Products Administration (NMPA), focused on verifying adherence to the *Good Manufacturing Practice for Medical Devices* and its specific appendix for *Sterile Medical Devices*. During the inspection, authorities confirmed that the company had ceased production, evidenced by the absence of medical device raw materials and finished products on site. This finding aligned with a production stoppage report the company had previously submitted to relevant regulatory bodies on May 28, 2018. As a result, Yunnan Chuxiong Medical Device Co., Ltd. is prohibited from resuming any production activities until it successfully passes a subsequent re-inspection by the Yunnan Provincial Drug Administration, ensuring all quality and safety requirements are fully met.