483
Adilia M. Hormigo, M.D.FDA 483 - Adilia M. Hormigo, M.D. - January 08, 2020
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Record Details
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.
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ID · 662a5d06-8375-43ba-9345-44ce474e518c