FDA 483 - Medical City Plano IRB - December 06, 2024

An FDA inspection of Medical City Plano IRB in Plano, TX, revealed two significant observations. The firm failed to prepare and maintain IRB meeting minutes with sufficient detail regarding voting actions, including issues with recusal and abstention documentation. Additionally, the IRB lacked written procedures for conducting its initial review of research, specifically concerning chairman voting, quorum, and the distinction between abstentions and recusals.