Prof. Bernardo Leon Rapoport
Form 483 issued January 29, 2026 · Johannesburg, South Africa
- Inspection
- Jan 20 – Jan 29, 2026
- Investigator
- Richard W. Berning
- Observations
- 2
- Pages
- 10
- FEI number
- 3021927419
In short: On January 29, 2026, FDA issued a Form 483 with 2 observations to Prof. Bernardo Leon Rapoport in Johannesburg, South Africa (FEI 3021927419) after an inspection that ran Jan 20 – Jan 29, 2026. The investigator was Richard W. Berning. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 312.60 (general responsibilities of investigators).
At a glance
2 of 2 observations on this 483 concern clinical (bimo).
Most cited: 21 CFR 312.60 (1×) · 312.62(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
An investigation was not conducted in accordance…
- 02
Failure to prepare or maintain adequate and accurate case histories with respect to observations and data…
This inspection in context
Richard W. Berning
3 documents · 2016–2026
Cites 312.50 (general responsibilities of sponsors) more than any other section. Most of their documents are for sites in China.
The firmProf. Bernardo Leon Rapoport history
The site's inspection history, in date order.
Similar 483sOther sites cited under 312.60
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Prof. Bernardo Leon Rapoport?
FDA listed 2 observations on this Form 483, mostly about clinical (BIMO). The most-cited regulation is 21 CFR 312.60 (general responsibilities of investigators). The opening words of each observation are shown on this page.
Who inspected Prof. Bernardo Leon Rapoport?
Richard W. Berning is named on this Form 483, for the inspection of Jan 20 – Jan 29, 2026. Each investigator has a profile showing what they cite most.
When was Prof. Bernardo Leon Rapoport inspected by FDA?
The inspection ran Jan 20 – Jan 29, 2026, and the Form 483 is dated January 29, 2026.
How do I get the full Form 483 for Prof. Bernardo Leon Rapoport?
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