FDA 483 - Creighton University IRB - April 07, 2022

An FDA inspection of Creighton University IRB in Omaha, NE, revealed significant deficiencies across multiple areas of its operations. The firm failed to maintain required records for three years post-research completion and did not follow its own written procedures for reviewing research. Additionally, meeting minutes were found to be insufficiently detailed, lacking crucial information regarding attendance, actions, and voting records.