FDA 483 - Bernardo Leon Rapoport, M.D. - January 29, 2026
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 07bed9a9-6e0d-4a61-a8e4-72128bfb85ba