FDA 483 - Rachel H. Epstein, M.D. - March 04, 2022

Rachel H. Epstein, M.D. in Highland Park, IL, a clinical investigator, was cited with three observations during an FDA inspection. The inspection revealed significant issues with adherence to investigational plans, including unperformed protocol assessments and incomplete case histories regarding adverse events and surgical procedures. Additionally, the firm failed to maintain adequate investigational drug disposition records, with instances of drug dispensed prior to subject enrollment and undocumented drug unit dispositions.