FDA 483 - Seton Family of Hospitals Institutional Review Board (SFOH IRB) - March 22, 2019

An inspection of Seton Family of Hospitals Institutional Review Board (SFOH IRB) in Austin, TX, revealed significant deficiencies in its review processes and recordkeeping. The IRB failed to adequately document pediatric study reviews, conduct timely continuing reviews of ongoing research, and maintain required records due to a catastrophic system failure without proper backup. These issues indicate a lack of robust oversight and data integrity for human subject protection.