China NMPA Inspection - Henan Tuoren Blood Filtration Medical Equipment Co., Ltd. - August 10, 2017

An unannounced inspection by the State Food and Drug Administration (SFDA) uncovered significant deficiencies in the quality management system of Henan Tuoren Blood Filtration Medical Device Co., Ltd. The inspection, conducted under the regulatory framework of the "Good Manufacturing Practice for Medical Devices," revealed multiple critical issues across various operational areas. Key violations included an unclean production environment with inadequate isolation between clean and non-clean areas, leading to contamination risks, and a lack of proper material transfer buffers. The company also failed to provide verification for the purification of compressed air used in product contact and exhibited poor management of intermediate process water storage tanks. Production management issues involved inconsistent and incomplete batch records, unlabelled semi-finished products, and discrepancies in sterilization procedures, including unverified equipment and outdated work instructions. Quality control failures included inconsistent data between reported and original records for particulate contamination and a lack of monitoring for process water. Given these serious non-compliances, the SFDA has mandated Henan Tuoren to immediately cease production for rectification. The company must assess product safety risks, recall any hazardous products, and will only be allowed to resume production upon successful completion of all corrective actions and passing a follow-up inspection.