China NMPA Inspection - Taicoboman (Hubei) Medical Technology Co., Ltd. - December 26, 2024

The National Medical Products Administration (NMPA) announced findings from an unannounced inspection of Taike Boman (Hubei) Medical Technology Co., Ltd., on December 26, 2024, revealing serious deficiencies in the company's quality management system. Key violations involved both plant facilities and production management. Firstly, the company's critical aseptic filling process and indirect support ampoule cleaning/sterilization process were co-located in the same functional room. This setup, detrimental to isolation, poses a significant cross-contamination risk, failing to meet the Good Manufacturing Practice for Medical Devices requirements for rational facility design and layout based on cleanliness levels. Secondly, a review of 2023 and 2024 reliability verification reports for aseptic processing showed critical details, such as simulated filling processes, were unrecorded. This contravenes the Good Manufacturing Practice for Medical Devices Appendix: Sterile Medical Devices, which mandates thorough validation and record-keeping for sterilization processes. Consequently, provincial drug regulatory authorities are mandated to implement strict control measures under Article 72 of the Regulations on the Supervision and Administration of Medical Devices. These include ordering an immediate suspension of production, conducting random inspections, and legally addressing any regulatory breaches. Furthermore, the company must assess product safety risks and initiate recalls for any potentially hazardous products in accordance with the Measures for the Administration of Medical Device Recalls. Production can only resume after all deficiencies are fully rectified and a successful re-inspection by the provincial authorities is completed.