China NMPA Inspection - Hunan Sanrui Biotechnology Co., Ltd. - April 03, 2025

The National Medical Products Administration (NMPA) announced an unannounced inspection of Hunan Sanrui Biotechnology Co., Ltd. on April 3, 2025, revealing serious deficiencies in its quality management system. The inspection identified multiple violations of the "Good Manufacturing Practice for Medical Devices." Key issues included inspection personnel lacking adequate training and using inconsistent testing parameters for disposable infusion disinfection connectors. The company also failed to equip itself with essential production and inspection equipment, such as ultrasonic welding and negative pressure suction devices for specific kits. Procurement controls were found deficient, with inconsistent raw material inspection reports and discrepancies in acceptance criteria versus actual measurements for items like aluminum foil and connector components. Production management was flawed, as the company did not confirm key processes after relocating in May 2024, specifically for assembling sterilization connectors. Quality control procedures for isopropanol content testing were inconsistent with product technical requirements. Furthermore, discrepancies existed between finished product inventory records and actual stock, hindering traceability. Finally, non-conforming semi-finished products were discovered without proper identification, recording, or handling protocols. In response, the Hunan Provincial Drug Administration is mandated to order a production suspension, conduct further inspections, and address legal violations under the "Regulations on the Supervision and Administration of Medical Devices." The company must assess product safety risks, recall any hazardous products, and can only resume production after comprehensive rectification and a successful re-inspection.