483
J. Robert FlaminiFDA 483 - J. Robert Flamini - March 11, 2024
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Record Details
An FDA inspection of J. Robert Flamini, a clinical investigator in Atlanta, GA, revealed a significant deviation from an investigational plan. Specifically, a pediatric subject in a study for partial-onset seizures was administered an incorrect dosage of the investigational product over an extended period. This indicates a failure to conduct the study in accordance with the approved protocol.
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ID · d766a527-9e35-4030-94b8-042b025ecf7b