FDA 483 - Bay Regional Medical Center IRB - June 24, 2011

An FDA inspection of Bay Regional Medical Center IRB in Bay City, MI, from June 22-24, 2011, revealed significant issues with the IRB's operations. The facility was cited for improperly using expedited review for ineligible research, failing to adhere to its own written review procedures, and maintaining inadequate meeting minutes regarding voting records. These observations indicate a need for improved compliance with regulatory standards for institutional review boards.