483
Issam MakhoulFDA 483 - Issam Makhoul - September 08, 2025
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Record Details
An FDA inspection of clinical investigator Issam Makhoul in Little Rock, AR, revealed a significant deviation from the investigational plan. The firm failed to ensure that all subjects met eligibility criteria before randomization into a study. Specifically, subjects using prohibited medications were randomized, compromising the integrity of the clinical trial.
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