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

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

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Record Details

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.

Company: Kalispell Regional Medical Center, Inc. IRB #4
Inspection Date: March 29, 2019
Product Type: Other
Office: Division of Human and Animal Food Operations - West VI
Person: Mark Babbitt (Grandfather, Fisherman, and loving life!)

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ID · a9673f41-f46c-410f-9384-858bf659463e