Overview
- 3 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2025-02-11.
At a glance
Inspections
3
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Feb 2025 – 11 Feb 2025 | Human Drugs | 483 | View 483 → |
| 5 Nov 2018 – 7 Nov 2018 | Human Drugs | Clean | |
| 12 Feb 2018 – 16 Feb 2018 | Human Drugs | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
11 Feb 2025
21 CFR 211.68(b)
Computer control of master formula records
Cited by Pushpa S Jayasekara, Catherine O Lamptey, Ofuje D Daniyan
11 Feb 2025
21 CFR 211.80(d)
Disposition recorded by lot identification
Cited by Pushpa S Jayasekara, Catherine O Lamptey, Ofuje D Daniyan
11 Feb 2025
21 CFR 211.80(d)
Status of Each Lot Identified
Cited by Pushpa S Jayasekara, Catherine O Lamptey, Ofuje D Daniyan
Investigators
FDA investigators tied to this site in the record.
Pushpa S Jayasekara1 insp.
Catherine O Lamptey1 insp.
Ofuje D Daniyan1 insp.
Marcellinus D Dordunoo1 insp.
Zakaria I Ganiyu1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.80(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind United Therapeutics Corporation's 1 Form 483
Source PDFs 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