China NMPA Inspection - Shanghai Amsino Medical Devices Co., Ltd. - October 30, 2018

Shanghai Yiyou Medical Devices Co., Ltd. underwent an unannounced compliance inspection on September 18-19, 2018, based on the Good Manufacturing Practice for Medical Devices. The inspection identified seven general deficiencies, indicating significant gaps in the company's quality management system. Key violations included improper storage in raw material and finished product warehouses, and outdated document control procedures, such as unrevised operating instructions, incorrect testing protocols, and a failure to update regulations and standards. The supplier review system was deemed inadequate, with new procedures implemented without proper internal approval. Furthermore, quality control procedures were not consistently followed, leading to inspections not meeting required standards and the use of incorrect testing methodologies. The company also failed to track and analyze customer feedback and conduct required quality data analysis, as evidenced by missing customer satisfaction records, quarterly reports, and complaint summaries. Finally, statistical data for corrective and preventive actions were not maintained as per company procedures. Consequently, the Shanghai Municipal Food and Drug Administration mandated the company to rectify all identified issues within a specified period. The company must assess product safety risks and, if necessary, recall any products posing hazards, in accordance with the Regulations on the Recall Management of Medical Devices. Follow-up inspections may occur, and the company is required to report its rectification status to the National Medical Products Administration.