China NMPA Inspection - Beijing Daqing Xige Technology Co., Ltd. - October 16, 2018

Beijing Daqing Xige Technology Co., Ltd. underwent an unannounced compliance inspection from September 17-19, 2018, regarding its dental implant products. The inspection, based on the Good Manufacturing Practice for Medical Devices and its implantable devices appendix, revealed significant deviations from quality management standards. Key violations included an incomplete organizational chart, inadequate cleanroom staffing, and overdue health checkups for product-handling personnel. The company failed to identify microbial contamination risks for sterile packaging and did not complete required reports or risk assessments following a change in its HA coating supplier. Furthermore, there was no audit of a critical coating subcontractor, and quality management personnel did not participate in supplier evaluations. Procedural deficiencies were noted in instrument self-calibration and laser particle counter calibration. Significant traceability issues emerged, with sales and delivery documentation frequently missing product or sterilization batch numbers and expiration dates. Nonconforming product control procedures were not adhered to, specifically lacking general manager approval for serious nonconformities. A recurring issue of expired reagents was also identified. Additionally, the company failed to analyze high microbial trends in process water and had deficiencies in its sample retention management, including non-compliant batch numbering and unclear retention dates. As a result, the company is required to promptly rectify all identified issues, assess product safety risks, and recall any potentially hazardous products. The Beijing Municipal Food and Drug Administration will conduct follow-up inspections and report the rectification status to the National Medical Products Administration.