FDA 483 - Tooraj J. Raoof, M.D. - August 02, 2019

An FDA inspection of Tooraj J. Raoof, M.D., a clinical investigator in Encino, CA, revealed significant deviations from investigational plans and study protocols for two human clinical studies involving investigational drugs. The firm failed to ensure subject eligibility criteria were met and conducted numerous out-of-window study visits without sponsor approval, compromising data integrity and subject safety.