483
Corbin Clinical Resources, LlcCorbin Clinical Resources, Llc – FDA 483, Dec 1, 2023
Record Details
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.
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