FDA 483 - Albert Einstein College of Medicine IRB - December 13, 2018

An FDA inspection of Albert Einstein College of Medicine Inc.'s Institutional Review Board (IRB) in Bronx, NY, revealed two significant observations. The inspection found deficiencies in the preparation and maintenance of IRB meeting minutes, specifically regarding vote tallies and attendance records. Additionally, the IRB failed to follow its own written procedures for reviewing research, particularly concerning the transition from paper to electronic records and the identification of conflicts of interest.