FDA 483 - Good Samaritan Medical Center IRB - September 11, 2009

An FDA inspection of Good Samaritan Medical Center IRB in West Palm Beach, FL, revealed significant deficiencies in its Institutional Review Board (IRB) operations. The IRB failed to consistently follow its own written procedures for research review, including proper member orientation, alternate member packet distribution, and risk determination. Additionally, the IRB conducted reviews without a proper quorum, did not maintain complete continuing review records, and kept inadequate meeting minutes regarding voting details.