FDA 483 - Aaron E. Miller, M.D. - April 21, 2022

An FDA inspection of Aaron E. Miller, M.D. in New York, NY, a clinical investigator, revealed significant deficiencies in the conduct of a clinical trial. Observations included failures to promptly report serious adverse events to the sponsor, multiple instances of not adhering to the investigational protocol, and inadequate record-keeping for investigational drug disposition. These issues indicate a lack of proper oversight and adherence to clinical trial regulations.