Drug factory · FDA FEI 3003825766
United Therapeutics Corporation
55 TW Alexander Drive, Durham, NC, United States
Problems found, fixed voluntarily at FDA's last inspection, Feb 28, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2012: 4 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Treprostinil | Makes it, tests it, packages it and labels it | United Therapeutics Corporation | 66302-206, 66302-300, 66302-302 +17 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 28, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| May 3, 2018 | No problems found | Bioresearch Monitoring | — |
| Feb 24, 2017 | No problems found | Drug Quality Assurance | — |
| Aug 21, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 27, 2013 | No problems found | Bioresearch Monitoring | — |
| Aug 2, 2012 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Feb 28, 2025 inspection
- Systems in place to comply with verification requirements FDCA 582(b)(4)
Your firm failed to have systems in place to enable compliance with the verification requirements of the DSCSA.
Registered with FDA for: analysis; label; manufacture; pack.