United Therapeutic Corporation
Form 483 issued February 11, 2025 · Beltsville, Maryland
- Inspection
- Feb 4 – Feb 11, 2025
- Observations
- 3
- Pages
- 4
- FEI number
- 3013584633
In short: On February 11, 2025, FDA issued a Form 483 with 3 observations to United Therapeutic Corporation in Beltsville, Maryland (FEI 3013584633) after an inspection that ran Feb 4 – Feb 11, 2025. Most observations concern materials and facilities & equipment; the most-cited regulation is 21 CFR 211.80 (general requirements).
At a glance
2 of 3 observations on this 483 concern materials.
Most cited: 21 CFR 211.80(d) (2×) · 211.68(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Each lot of components and drug product containers was not appropriately identified as to its status…
- 03
The distinctive code for each lot of components and closures is not used in recording the…
This inspection in context
Questions about this 483
What did FDA find at United Therapeutic Corporation?
FDA listed 3 observations on this Form 483, mostly about materials and facilities & equipment. The most-cited regulation is 21 CFR 211.80 (general requirements). The opening words of each observation are shown on this page.
When was United Therapeutic Corporation inspected by FDA?
The inspection ran Feb 4 – Feb 11, 2025, and the Form 483 is dated February 11, 2025.
How do I get the full Form 483 for United Therapeutic 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.