FDA 483 - Bernardo Leon Rapoport, M.D. - January 29, 2026

Prof. Bernardo Leon Rapoport, a clinical investigator in Johannesburg, South Africa, was cited for significant deviations from investigational plans and inadequate record-keeping during an FDA inspection. Observations included improper investigational product dosage and administration, failure to adhere to monitoring protocols, and inconsistent dose calculation methods. Additionally, the firm failed to maintain accurate case histories, with unattributed modifications and discrepancies in IP administration records.