483
Valley Health/Winchester Medical Center IRBValley Health/Winchester Medical Center IRB – FDA 483, Aug 9, 2022
Record Details
An FDA inspection of Valley Health/Winchester Medical Center IRB in Winchester, VA, revealed significant procedural deficiencies. The IRB failed to properly determine device study risk, maintain accurate lists of its members, and ensure detailed meeting minutes reflecting voting actions. These issues indicate a need for improved oversight and documentation practices within the IRB.
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