China NMPA Inspection - Chengdu Dicon Zhongke Biomedical Materials Co., Ltd. - May 28, 2018

An unannounced compliance inspection of Chengdu Dicon Zhongke Biomedical Materials Co., Ltd. occurred from May 10-11, 2018. The inspection, based on the Good Manufacturing Practice for Medical Devices and its Appendix for Implantable Medical Devices, identified seven general deficiencies in the production of Absorbable Fracture Internal Fixation Screws. Violations included the absence of calibration certificates for essential testing equipment, such as thermometers and drying ovens, and a failure to adequately document design and development changes. The company's batch production records were incomplete, lacking details for critical equipment. Furthermore, the laboratory environment did not meet specified temperature and humidity controls, and internal audits failed to analyze the root causes of product non-conformities like impurities. Issues also included the use of non-compliant molds without proper acceptance reports and a lack of records for purified water pipeline cleaning and disinfection. The Sichuan Provincial Food and Drug Administration was instructed to order the company to rectify these issues promptly, assess product safety risks, and initiate recalls for any hazardous products. Follow-up inspections and reporting to the National Medical Products Administration are also required.