FDA 483 - Abu Dayyeh, Barham, K., MD, MPH, Clinical Investigator - March 05, 2019

This FDA Form 483 was issued to Mayo Clinic in Rochester, MN, following an inspection of a clinical investigator. The inspection revealed that an investigation was not conducted in accordance with the signed agreement, investigational plan, applicable FDA regulations, and IRB conditions. Specifically, subjects were accrued to the study against exclusion criteria (esophagitis) and six subjects were not reconsented with an updated study consent form as instructed by the IRB.