FDA 483 - Best Vascular, Inc - July 11, 2025

An FDA inspection of Best Vascular, Inc. in Norcross, GA, from July 5-11, 2025, revealed a significant quality system deficiency. The firm failed to adequately document corrective and preventive action (CAPA) activities and effectiveness checks, as required by its own procedures. This indicates a breakdown in the company's quality management processes for its Class III medical device manufacturing.