Artegraft, Inc. – FDA 483, Jun 25, 2026

The inspection of LeMaitre Vascular, Inc. in North Brunswick, NJ, revealed significant deficiencies in quality system procedures. These issues include inadequate control over production, nonconforming product evaluation, product preservation, and ineffective corrective and preventive actions, as well as design and risk management failures. The findings indicate a lack of robust controls to ensure product quality, safety, and compliance with regulatory requirements.