FDA 483 - University Of Michigan - IRBMED - September 02, 2022

The FDA inspected the University of Michigan - IRBMED, an Institutional Review Board, from August 29 to September 2, 2022. The inspection revealed two observations related to the IRB's failure to follow its written procedures for continuing review of research and for communicating expedited review approvals to the full board. These findings indicate deficiencies in the IRB's adherence to its own established protocols for oversight of research studies.