Jardon Eye Prosthetics, Inc. – FDA 483, Mar 2, 2026

An FDA inspection of Jardon Eye Prosthetics, Inc. in Southfield, MI, revealed significant deficiencies in their quality management system for medical device manufacturing. The firm failed to adequately document critical processes such as risk management, nonconforming product control, internal audits, supplier evaluation, equipment maintenance, and management reviews. These issues indicate a systemic lack of documented procedures and controls essential for ensuring product quality and regulatory compliance.