China NMPA Inspection - Genemei Pharmaceutical (Qinghai) Co., Ltd. - October 24, 2024

The National Medical Products Administration (NMPA) conducted an unannounced inspection of Genemed Pharmaceutical (Qinghai) Co., Ltd., a medical device registrant, and its contract manufacturer, Xiejia (Qinghai) Medical Technology Co., Ltd., with findings announced on October 24, 2024. The inspections revealed serious deficiencies in the quality management systems of both companies, failing to comply with the Good Manufacturing Practices (GMP) for Medical Devices and its Appendix on Sterile Medical Devices.

Genemed Pharmaceutical exhibited critical issues, including unclear appointment of its management representative, an unqualified quality manager lacking relevant experience, and a failure to conduct design conversion activities after changing contract manufacturers. The company also lacked adequate records for raw material procurement, inspection, and supplier management. Production records showed inconsistencies in prescription ratios and lacked traceability for product packaging and specifications. Furthermore, Genemed failed to provide sterilization confirmation reports following a change in sterilization supplier. Genemed has voluntarily applied to cancel its medical device registration certificate. The provincial authority is mandated to monitor the company, urge maintenance of quality management, assess product safety risks, and recall products in accordance with the "Regulations on the Recall of Medical Devices" if hazards are identified. Other violations of the "Regulations on the Supervision and Administration of Medical Devices" will be addressed legally.

Xiejia Medical Technology was found to have inadequate training for quality control personnel. Facility issues included an unzoned warehouse area with un-marked products from other manufacturers and an an open breather vent on a pure water tank without a filter. Critically, non-conforming products were destroyed without the required client review and approval. Xiejia Medical Technology has been ordered to suspend production and rectify all deficiencies. Production resumption is contingent upon successful re-inspection by the provincial drug regulatory authority, and any violations of the "Regulations on the Supervision and Administration of Medical Devices" will be handled legally.