FDA 483 - VA Medical Center IRB, W. G. (Bill) Hefner Salisbury - December 07, 2023

The FDA inspected the VA Medical Center IRB, W. G. (Bill) Hefner Salisbury, and identified a significant non-compliance regarding its membership composition. The Institutional Review Board failed to include at least one member unaffiliated with the institution for an extended period from November 2022 through September 2023. This indicates a serious lapse in regulatory compliance for IRB operations.