ICON PLC
Form 483 issued June 13, 2025 · Lenexa, Kansas
- Inspection
- Jun 9 – Jun 13, 2025
- Investigator
- Sylvestre K. Dossou
- Observations
- 3
- Pages
- 2
- FEI number
- 3020784373
In short: On June 13, 2025, FDA issued a Form 483 with 3 observations to ICON PLC in Lenexa, Kansas (FEI 3020784373) after an inspection that ran Jun 9 – Jun 13, 2025. The investigator was Sylvestre K. Dossou. The most-cited regulation is 21 CFR 320.29 (analytical methods for an in vivo bioavailability or bioequivalence study).
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
1-In study ^^ for the the firm used calibration standards and QC samples outside the established…
- 02
2-In study ^ *4’ for the ^ *4’ a run was stopped due to instrument related…
- 03
3- In study (b)(4) for the (b)(4| samples for subject were…
This inspection in context
Sylvestre K. Dossou
2 documents · 2025–2026
Cites 320.29 (analytical methods for an in vivo bioavailability or bioequivalence study) more than any other section. Most of their documents are for sites in Delaware.
The firmICON PLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 320.29
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ICON PLC?
FDA listed 3 observations on this Form 483. The most-cited regulation is 21 CFR 320.29 (analytical methods for an in vivo bioavailability or bioequivalence study). The opening words of each observation are shown on this page.
Who inspected ICON PLC?
Sylvestre K. Dossou is named on this Form 483, for the inspection of Jun 9 – Jun 13, 2025. Each investigator has a profile showing what they cite most.
When was ICON PLC inspected by FDA?
The inspection ran Jun 9 – Jun 13, 2025, and the Form 483 is dated June 13, 2025.
How do I get the full Form 483 for ICON PLC?
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.