FDA 483 - Jay E. Gladstein, MD - July 12, 2019

An FDA inspection of Jay E. Gladstein, MD in Los Angeles, CA, identified a significant issue regarding adherence to the investigational plan. The firm failed to conduct an investigation in accordance with its plan, specifically concerning dispensing errors where three study subjects received incorrect study drugs. Two of these subjects subsequently dosed with the wrong medication, posing a potential risk to their safety.