FDA 483 - Robling Medical Inc - August 21, 2025

Robling Medical LLC, a contract manufacturer in Youngsville, NC, was inspected by the FDA from August 18-21, 2025. The inspection revealed a significant issue with the firm's corrective and preventive action (CAPA) system, specifically regarding incomplete documentation and discrepancies in closure dates on the CAPA log. This indicates a breakdown in quality system controls.