FDA 483 - Columbia University Medical Center IRB - August 31, 2022

Columbia University Medical Center IRB, an Institutional Review Board in New York, NY, was cited with a Form 483 for deficiencies in its operations. The inspection revealed that the IRB did not consistently ensure the presence of a nonscientific member or meet quorum requirements during convened meetings for FDA-regulated research. Furthermore, the firm failed to maintain adequate meeting minutes, specifically lacking sufficient detail on attendance and voting records.