Overview
- 6 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-28.
At a glance
Inspections
6
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 19 Feb 2025 – 28 Feb 2025 | Human Drugs | 483 | View 483 → |
| 30 Apr 2018 – 3 May 2018 | Human Drugs | Clean | |
| 21 Feb 2017 – 24 Feb 2017 | Human Drugs | Clean | |
| 17 Aug 2015 – 21 Aug 2015 | Human Drugs | 483 | View 483 → |
| 25 Sep 2013 – 27 Sep 2013 | Human Drugs | Clean | |
| 2 Aug 2012 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
28 Feb 2025
FDCA 582(b)(4)
Systems in place to comply with verification requirements
Cited by Janet A Rajan
21 Aug 2015
21 CFR 211.198(a)
Complaint Handling Procedure
Cited by Lillie D Witcher, Metitia G Sanders, Tamara M Casselman, Metitia M Gramby
21 Aug 2015
21 CFR 211.198(a)
Complaint Handling Procedure
Cited by Lillie D Witcher, Metitia G Sanders, Tamara M Casselman, Metitia M Gramby
Investigators
FDA investigators tied to this site in the record.
Janet A Rajan1 insp.
Betsy C Galliher1 insp.
Diane E Bruce1 insp.
Sonya M Edmonds1 insp.
Lillie D Witcher1 insp.
Metitia G Sanders1 insp.
Tamara M Casselman1 insp.
Metitia M Gramby1 insp.
Seneca D Toms1 insp.
Penny H Mccarver1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.198(a) | Cited across public-safe Form 483 observations | 2x |
| FDCA 582(b)(4) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind United Therapeutics Corporation's 2 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat