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

Source: https://www.keypedia.com/records/483/bernardo-leon-rapoport-md/07bed9a9-6e0d-4a61-a8e4-72128bfb85ba

> FDA 483 for Bernardo Leon Rapoport, M.D. on January 29, 2026. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Bernardo Leon Rapoport, M.D.
- Inspection Date: 2026-01-29
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Documents

- [483 - 2026-01-29](https://www.keypedia.com/records/483/bernardo-leon-rapoport-md/cb99b7fe-52a4-4790-bdbd-04d365e1fb42)

## Related Officers

- [Bioresearch Monitoring Foreign Inspection Cadre Member](https://www.keypedia.com/people/richard-w-berning/4637e321-8803-4fcf-911f-bbc810c3487d)

Company: https://www.keypedia.com/companies/bernardo-leon-rapoport-md/b82110bd-bd6b-4e5a-be1f-15406e1d8e18

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8