United Therapeutics Corporation
Form 483 issued February 28, 2025 · Research Triangle Park, North Carolina
- Inspection
- Feb 28, 2025
- Investigator
- Janet A. Rajan
- Observations
- 1
- Pages
- 3
- FEI number
- 3003825766
In short: On February 28, 2025, FDA issued a Form 483 with 1 observation to United Therapeutics Corporation in Research Triangle Park, North Carolina (FEI 3003825766) after an inspection that ran Feb 28, 2025. The investigator was Janet A. Rajan.
What FDA observed
Preview: the opening words of each observation- 01FDCA 582(b)(4)
Your firm failed to have systems in place to enable compliance with the verification…
This inspection in context
Janet A. Rajan
13 documents · 2021–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in New Jersey.
The firmUnited Therapeutics Corporation history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at United Therapeutics Corporation?
FDA listed 1 observation on this Form 483. The opening words of each observation are shown on this page.
Who inspected United Therapeutics Corporation?
Janet A. Rajan is named on this Form 483, for the inspection of Feb 28, 2025. Each investigator has a profile showing what they cite most.
When was United Therapeutics Corporation inspected by FDA?
The inspection ran Feb 28, 2025, and the Form 483 is dated February 28, 2025.
How do I get the full Form 483 for United Therapeutics Corporation?
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.