FDA 483 - Robling Medical Inc - April 06, 2026
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 38838696-470b-4ebc-af28-2f17048125dd