FDA 483 - VistaMed Ltd t/a Freudenberg Medical - April 03, 2025

An FDA inspection of VistaMed Ltd t/a Freudenberg Medical in Carrick-on-Shannon, Ireland, revealed significant deficiencies in their contract manufacturing operations for the BioMimics 3D Vascular Stent System. Observations included inadequate process control procedures, insufficient procedures for incoming product acceptance, and a failure to properly identify the acceptance status of products, specifically regarding sterile labeling for non-sterilized devices. These issues indicate a lack of robust quality system controls.