National Marrow Donor Program IRBApril 4, 2023

FDA 483 - National Marrow Donor Program IRB - April 04, 2023

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Record Details

An FDA inspection of the National Marrow Donor Program IRB in Minneapolis, MN, revealed a significant deficiency in their review procedures. The Institutional Review Board improperly utilized expedited review for changes to previously-approved research protocols that were not minor in nature. This indicates a failure to adhere to appropriate review standards for research modifications.

Company: National Marrow Donor Program IRB
Inspection Date: April 4, 2023
Product Type: Other
Office: Minneapolis District Office
Person: Sharon L. Matson (Investigator)

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ID · bf9c3870-7d31-4559-85c4-8c293e741e77