Roger S. Keresztes, M.D
Form 483 issued December 12, 2024 · Stony Brook, New York
- Inspection
- Nov 25 – Dec 12, 2024
- Investigator
- Bernardica T. Sculac Stern
- Observations
- 1
- Pages
- 3
- FEI number
- 3015471867
In short: On December 12, 2024, FDA issued a Form 483 with 1 observation to Roger S. Keresztes, M.D in Stony Brook, New York (FEI 3015471867) after an inspection that ran Nov 25 – Dec 12, 2024. The investigator was Bernardica T. Sculac Stern. Most observations concern clinical (BIMO); the most-cited regulation is 21 CFR 312.60 (general responsibilities of investigators).
At a glance
1 of 1 observations on this 483 concern clinical (bimo).
Most cited: 21 CFR 312.60 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Ah investigation was not conducted in accordance with the signed statement of…
This inspection in context
Bernardica T. Sculac Stern
1 document · 2024
Cites 312.60 (general responsibilities of investigators) more than any other section. Most of their documents are for sites in New York.
The firmRoger S. Keresztes, M.D 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 Roger S. Keresztes, M.D?
FDA listed 1 observation 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 Roger S. Keresztes, M.D?
Bernardica T. Sculac Stern is named on this Form 483, for the inspection of Nov 25 – Dec 12, 2024. Each investigator has a profile showing what they cite most.
When was Roger S. Keresztes, M.D inspected by FDA?
The inspection ran Nov 25 – Dec 12, 2024, and the Form 483 is dated December 12, 2024.
How do I get the full Form 483 for Roger S. Keresztes, M.D?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.