China NMPA Inspection - Guizhou Angel Medical Equipment Co., Ltd. - October 29, 2024

The National Medical Products Administration (NMPA) announced findings from unannounced inspections revealing serious quality management system deficiencies at an unnamed medical device manufacturer and Hubei Xianming Medical Device Co., Ltd. The announcement was made on October 28, 2024. The first inspected company demonstrated critical issues, including a purified water storage tank directly exposed to the atmosphere, a lack of traceability for raw materials like masterbatch and cyclohexanone in production records, untraceable PVC recycling, and inadequate labeling and segregation of semi-finished and non-conforming products. Furthermore, non-compliant raw materials were improperly crushed and reused without required identification, isolation, or assessment. These actions violate the Good Manufacturing Practice for Medical Devices (GMP) and its Appendix for Sterile Medical Devices. Hubei Xianming Medical Device Co., Ltd. also exhibited significant non-compliance. Problems included an injection molding machine operating beyond its specified temperature range without intervention, absence of verification records for special process equipment, and untraceable pulverizer usage and recycled material quantities. Discrepancies were found between recorded and actual ethylene oxide sterilization dosages, and numerous raw materials and intermediate products were unlabeled or mislabeled. Quality control failures involved inspection reports with incorrect tester/reviewer duty dates and inconsistent culture media preparation records. These findings contravene regulatory "Specifications" (likely GMP-related standards). Both companies have acknowledged these systemic failures. The NMPA has directed local provincial drug regulatory authorities to order immediate production suspension, conduct supervisory sampling, pursue legal action for violations, and mandate product safety risk assessments, potentially leading to recalls. Production may only resume after all deficiencies are fully rectified and a successful re-inspection occurs.