FDA 483 - Adilia M. Hormigo, M.D. - January 08, 2020

An FDA inspection of Adilia M. Hormigo, M.D. in New York, NY, identified a failure to ensure proper monitoring of a clinical study and adherence to the investigational plan. Specifically, the study experienced a lapse in IRB approval during which subjects received investigational vaccine products, and Quality of Life questionnaires were not performed as scheduled for several subjects. These issues indicate a lack of oversight in conducting the clinical trial.