FDA 483 - Gregory A. Guell, M.D. - October 31, 2022

An FDA inspection of Suncoast Research Group Llc in Miami, FL, revealed significant deficiencies in maintaining accurate case histories for a clinical study. The firm failed to report adverse events, accurately document AE start and end dates, record new concomitant medications, and ensure proper investigational product accountability and compliance. These issues indicate a serious lack of adherence to clinical trial record-keeping standards.