China NMPA Inspection - Jiangxi Meilin Kangda Pharmaceutical Co., Ltd. - July 19, 2023

The National Medical Products Administration (NMPA) conducted a recent unannounced inspection of Jiangxi Meilin Kangda Pharmaceutical Co., Ltd., with findings announced on July 19, 2023. The inspection uncovered serious deficiencies in the company's quality management system, specifically non-compliance with the *Good Manufacturing Practice for Medical Devices* and its *Appendix for Sterile Medical Devices*. Primary violations included significant issues within plant and facilities, where the ethylene oxide sterilization room and analytical cleaning room were interconnected without physical isolation, posing a substantial risk of cross-contamination. Furthermore, during design and development, the company failed to adequately verify and reconcile inconsistent quality inspection standards for a new supplier's raw material (nonwoven fabric). This oversight could compromise the safety and effectiveness of their medical device products, violating requirements for risk evaluation of material changes. In response, the Jiangxi Provincial Drug Administration is required, under Article 72 of the *Regulations on the Supervision and Administration of Medical Devices*, to suspend the company's production. Jiangxi Meilin Kangda Pharmaceutical Co., Ltd. must now undertake a comprehensive assessment of product safety risks, initiate recalls for any potentially hazardous products, and implement full rectification of all identified deficiencies. Production resumption is contingent upon the successful completion of all corrective actions and a subsequent re-inspection by the provincial authority.