Overview
- 9 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-05-02.
At a glance
Inspections
9
Form 483s
6
EIRs
1
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Apr 2024 – 2 May 2024 | Human Drugs | 483 | View 483 → |
| 16 Mar 2017 – 31 Mar 2017 | Human Drugs | 483 | View 483 → |
| 7 Jul 2014 – 11 Jul 2014 | Human Drugs | Clean | |
| 9 Jun 2014 – 13 Jun 2014 | Human Drugs | 483 | On file |
| 20 May 2013 – 29 May 2013 | Human Drugs | 483 | On file |
| 12 Dec 2011 | Not recorded | Clean | |
| 28 Jun 2011 | Not recorded | Clean | |
| 11 Feb 2011 | Not recorded | 483 | On file |
| 7 Nov 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
2 May 2024
21 CFR 211.113(b)
Procedures for sterile drug products
Cited by Mindy M Chou, Annet R Rajan, Janet A Rajan
2 May 2024
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Mindy M Chou, Annet R Rajan, Janet A Rajan
2 May 2024
21 CFR 211.84(d)(2)
Reports of Analysis (Components)
Cited by Mindy M Chou, Annet R Rajan, Janet A Rajan
31 Mar 2017
21 CFR 211.192
Investigations of discrepancies, failures
Cited by Jonathan W Chapman, Stacie A Woods
31 Mar 2017
21 CFR 211.22(d)
Procedures not in writing, fully followed
Cited by Jonathan W Chapman, Stacie A Woods
Investigators
FDA investigators tied to this site in the record.
Ernest Bizjak4 insp.
Jonathan W Chapman2 insp.
Mindy M Chou1 insp.
Annet R Rajan1 insp.
Janet A Rajan1 insp.
Stacie A Woods1 insp.
Nebil A Oumer1 insp.
Patricia F Hughes Troost1 insp.
Brooke K Higgins1 insp.
Monique-Rac Lester1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.192 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.113(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.22(d) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.68(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.84(d)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind United Therapeutics Corporation's 6 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