FDA 483 - Fermatex Vascular Technologies - June 24, 2025

An FDA inspection of Fermatex Vascular Technologies in Wall Township, NJ, revealed significant deficiencies in manufacturing controls, environmental monitoring, and corrective and preventive action procedures. The firm failed to record critical manufacturing equipment settings in device history records and lacked adequate environmental monitoring for its cleanroom. Additionally, procedures for analyzing quality data for non-conforming products were not established.