FDA 483 - Mount Sinai School of Medicine

An FDA inspection of the Institutional Review Board (IRB) at Mount Sinai School of Medicine in New York revealed multiple deficiencies related to IRB meeting procedures and membership. Observations included a lack of a non-scientific member at a meeting, absence of voting records, and issues with quorum and the designation and voting practices of alternate members. These findings indicate a failure to adhere to proper IRB operational guidelines.