FDA 483 - Kalispell Regional Medical Center, Inc. IRB #4 - March 29, 2019

During an inspection of Kalispell Regional Medical Center, Inc.'s Institutional Review Board (IRB) in Kalispell, MT, the FDA observed a significant procedural error. The IRB improperly used an expedited review process for a research protocol involving an Investigational New Drug (IND) and active study subjects, which did not meet the criteria for expedited review. This indicates a failure to follow appropriate human subject protection regulations.