China NMPA Inspection - Tianjin Yangquan Medical Equipment Co., Ltd. - June 23, 2017

On June 21, 2017, the State Food and Drug Administration (SFDA) announced findings from an unannounced inspection of Tianjin Yangquan Medical Device Co., Ltd. The company was found to have serious deficiencies in its quality management system, non-compliant with medical device Good Manufacturing Practices (GMP) and other regulations. Key violations included: failure to update its Medical Device Registration Certificate for multiple production addresses, inadequate hazardous materials storage at both facilities, and significant discrepancies in procurement records for raw materials like resin, leading to untraceable stock. Production management issues involved incomplete manufacturing records for disposable blood perfusion devices, missing crucial process details, and unauthorized deviations in sterilization procedures and locations. Furthermore, the quality control department used expired testing equipment without current calibration, and lacked evidence for required product and raw material testing. Internal audit records were also incomplete. The SFDA instructed the company to immediately cease production for rectification. Tianjin Yangquan Medical Device Co., Ltd. is required to assess product safety risks, recall any hazardous products, and address all identified deficiencies. Production resumption is contingent upon successful rectification and passing a subsequent inspection by provincial authorities. Serious legal action will be taken for non-compliance with medical device regulations.