Summary of FDA Warning Letters to IRBs

In 2011, the Food and Drug Administration (FDA) issued five warning letters to IRBs. None of the five was from an AAHRPP-accredited organization. Since 1996, the FDA has issued 108 warning letters to IRBs, one of which was from an organization that was accredited at the time of the inspection and three others which were from organizations that later obtained accreditation. FDA warning letters can be found here.