483
Bay Regional Medical Center IRBBay Regional Medical Center IRB – FDA 483, Jun 24, 2011
Record Details
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.
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