FDA 483 - Sameek Roychowdhury, MD - January 22, 2021

An FDA inspection of Sameek Roychowdhury, MD in Columbus, OH, revealed significant deviations from the investigational plan, including the enrollment of ineligible subjects and untimely reporting of serious adverse events. The firm also failed to maintain adequate and accurate case histories, with missing critical information and insufficient documentation for serious adverse event reporting.