Robling Medical Inc – FDA 483, Apr 6, 2026

Robling Medical LLC, a contract manufacturer in Youngsville, NC, was inspected by the FDA and received a Form 483 with two observations. The inspection revealed significant delays in implementing corrective and preventive actions (CAPAs) and a failure to adequately document risk management processes, specifically a Process Failure Mode and Effects Analysis (PFMEA) for a sterile medical device. These issues indicate deficiencies in the firm's quality system regarding timely issue resolution and risk assessment.