FDA 483 - Access Vascular, Inc - November 25, 2025

An FDA inspection of Access Vascular, Inc. in Billerica, MA, revealed inadequate procedures for corrective and preventive actions (CAPA). The firm's CAPA procedure did not ensure verification of effectiveness for all actions, with specific instances found where verification was not required based solely on document creation. This indicates a moderate severity issue regarding the firm's quality system for medical device manufacturing.