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

Source: https://www.globalkeysolutions.net/records/china_inspection/hebei-ruinuo-medical-instrument-co-ltd/6f51cd14-3745-46f2-840d-f5f6e34b4c54/
Source feed: China

> China NMPA unannounced inspection for Hebei Ruinuo Medical Instrument Co., Ltd. published 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 Prac

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## Details

- Record Type: CHINA_INSPECTION
- Title: Notification of Unannounced Inspection of Hebei Ruinuo Medical Instrument Co., Ltd.
- Company Name: Hebei Ruinuo Medical Instrument Co., Ltd.
- Publication Date: 2018-07-16
- Product Type: Device
- Summary: 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.

Company: https://www.globalkeysolutions.net/companies/hebei-ruinuo-medical-instrument-co-ltd/1b42e48e-09e6-41ce-abdd-1077888b4082/