China NMPA Inspection - Beijing Guorui Huihuang Medical Equipment Co., Ltd. - June 07, 2018

An unannounced compliance inspection of Beijing Guorui Huihuang Medical Devices Co., Ltd. was conducted on May 21, 2018, based on the Good Manufacturing Practice for Medical Devices. The inspection revealed significant operational non-compliance concerning the company's production facilities. At the time of inspection, the company had ceased production at its original registered address in Haidian District, as evidenced by a production suspension notice filed on May 4, 2018. The site was devoid of personnel or equipment. Furthermore, the company's intended new production address in Changping District was still undergoing renovation, indicating that no authorized and operational manufacturing site existed during the inspection. This situation constitutes a critical violation of regulatory requirements for maintaining a licensed production environment. To rectify these issues, the company is mandated to take several actions. Beijing Guorui Huihuang Medical Devices Co., Ltd. must first secure a production license address change permit. Following this, a comprehensive written report must be submitted to the Beijing Municipal Food and Drug Administration. Crucially, the company is prohibited from resuming production until the Municipal Administration conducts a subsequent inspection and officially confirms that the new facility fully complies with all regulatory standards. The Beijing Municipal Food and Drug Administration is also required to inform the National Medical Products Administration upon the company's verified resumption of production.