FDA 483 - Prithviraj Bose, M.D. - April 30, 2026

An FDA inspection of Prithviraj Bose, MD, a Clinical Investigator in Houston, TX, revealed significant deviations from the investigational plan. The primary concern was the failure to ensure subjects met all eligibility criteria before randomization into a study. This included enrolling subjects who did not meet specific inclusion criteria and randomizing a subject before all required screening assessments were complete.