FDA 483 - Glens Falls Hospital IRB - August 14, 2023

Glens Falls Hospital IRB in Glens Falls, NY, was inspected by the FDA from August 7-14, 2023. The inspection revealed that the IRB failed to conduct continuing review of research at least once per year, leading to significant lapses in approval for a Humanitarian Use Device study. Additionally, the IRB did not notify clinical investigators of these lapses.