483
Robling Medical IncRobling Medical Inc – FDA 483, Aug 21, 2025
Record Details
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.
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- Atlanta District Office
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ID · 767d7269-a5a3-4d5e-83e7-b77a3b37a416
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