China NMPA Inspection - Hebei Ruinuo Medical Instrument Co., Ltd. - July 16, 2018

Hebei Ruinuo Medical Device Co., Ltd. was subject to an unannounced compliance inspection from June 27-28, 2018. Based on the *Good Manufacturing Practice for Medical Devices* and its *Appendix for Implantable Medical Devices*, the inspection revealed eight general manufacturing defects related to the production of Polypropylene Hernia Repair Patches. Key issues included inconsistencies between sterility test procedures and records regarding incubation temperatures, and a failure to statistically analyze quality control data, incoming inspection, and environmental monitoring data as required by internal procedures. Facility-related non-compliances were also identified, such as a cleanroom door opening incorrectly and a lack of cleanliness status markings on equipment. Additionally, critical documentation was found to be deficient, with sterilization reconfirmation plans missing product-specific information. The ethylene oxide analysis library was inadequate, lacking essential temperature control and monitoring. Finally, laboratory practices exhibited improper labeling of chemical reagents and bacterial strains. As a result, the Hebei Provincial Food and Drug Administration has mandated the company to rectify these deficiencies, assess product safety risks, and initiate recalls for any potentially hazardous products. Follow-up inspections are planned, and the provincial authority must report the rectification progress to the National Medical Products Administration.