China NMPA Inspection - Tianjin Yangquan Medical Equipment Co., Ltd. - May 27, 2016

An unannounced inspection of Tianjin Zhengtian Medical Device Co., Ltd. was conducted by the Tianjin Municipal Market and Quality Supervision and Management Commission, with the findings detailed in a report published on May 27, 2016. The inspection revealed that the company's operational practices did not comply with the stringent requirements of the Good Manufacturing Practice for Medical Devices (GMP). Key issues identified included significant deficiencies within the company's quality management system, indicating a failure to adhere to established regulatory standards for medical device manufacturing. This action falls under the regulatory oversight of the National Medical Products Administration (NMPA). Consequently, Tianjin Zhengtian Medical Device Co., Ltd. has been formally ordered to undertake corrective actions, requiring them to rectify all identified shortcomings within their quality management system and manufacturing processes within a specified period to achieve full compliance with GMP regulations.