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

Between January 20 and January 29, 2026, the FDA conducted an inspection of the clinical research site of Prof. Bernardo Leon Rapaport in Johannesburg, South Africa. The inspection identified critical failures in adhering to the investigational plan and maintaining accurate clinical records under the Food, Drug, and Cosmetic Act framework. Key violations included the administration of investigational drugs at concentrations higher than the protocol allowed, which was linked to serious adverse events such as impaired kidney function and severe diarrhea. Additionally, the site failed to follow mandated infusion durations and patient monitoring requirements. Investigators also observed that drug doses were calculated using incorrect patient weights, deviating from the required baseline measurements. Record-keeping practices were significantly flawed. The FDA noted numerous instances where data was modified without identifying who made the change or when. Furthermore, source documents contained implausible information, such as records indicating that drug infusions started before the physician had signed off on the prescription or before the pharmacy had finished mixing the medication. These findings are currently classified as observations and do not constitute a final agency decision. Prof. Rapaport is required to respond to the FDA with a detailed plan for corrective actions to address these systemic deficiencies and ensure the safety of trial participants and the integrity of the data collected.