China NMPA Inspection - Jiangsu Weizhen Biomedical Technology Co., Ltd. - October 29, 2024

The National Medical Products Administration (NMPA) announced on October 25, 2024, findings from unannounced inspections that uncovered significant quality management system deficiencies at two medical device companies. One unnamed company demonstrated issues with raw material quality control, including a lack of testing data for magnetic bead diameter and solid content, and an inadequate supplier agreement failing to specify quality requirements. Furthermore, the company had incomplete testing items for positive and negative control raw materials and failed to provide required cell bank records and operation logs. These deficiencies violated the *Good Manufacturing Practice for Medical Devices* and its *Appendix for In Vitro Diagnostic Reagents*. Xinjiang Likang Xiangyun Biotechnology Co., Ltd. also faced violations. Its finished immunoglobulin A assay kit inspection procedures had fewer testing items than product specifications and lacked risk assessment. The company could not provide source information for linear samples, impacting product traceability. A temporal logical error was also identified in its 2023 management review report. Due to these serious quality management system failures, both companies are ordered to immediately suspend production. Regulatory authorities will pursue legal actions, mandate product safety risk assessments, and recall any products presenting safety hazards. Production may only resume after complete rectification of all deficiencies and a successful re-inspection by provincial drug regulatory authorities.