FDA 483 - Corbin Clinical Resources, Llc - December 01, 2023

Corbin Clinical Resources, Llc, a medical device manufacturer in Cumberland, MD, was cited by the FDA for not adequately establishing procedures for design input. The inspection revealed discrepancies between the intended use defined in design records and device clearance letters for their PrecisionPoint® Biopsy Needle Guide and Perineologic™ Access Needle devices. Additionally, a claimed storage temperature on device labeling was not verified or validated.