United Therapeutics Corporation
FDA inspection history in Silver Spring, Maryland, 2024
- 1
- Form 483
Every document, by year
- Form 483
2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One Form 483, at Silver Spring, Maryland.
Cited most
Across all United Therapeutics observations on file
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.192Production record review1
- 21 CFR 211.84(d)(2)Testing and approval or rejection of components, drug product containers, and closures1
The complete United Therapeutics file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Silver Spring, Maryland
One Form 483 · 2024 · 3 observations
Latest: Form 483, May 2, 2024 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-05-02 | 483 Form 483 | Silver Spring, Maryland | 3 | $99 |
Investigators on these documents
FEI number 3003368324 · most recent document May 2, 2024
About United Therapeutics Corporation
How many FDA Form 483s has United Therapeutics Corporation received?
FDA Intel has 1 Form 483 on file for United Therapeutics Corporation; the most recent is dated May 2, 2024.
When was United Therapeutics Corporation last inspected by FDA?
The most recent FDA inspection document on file for United Therapeutics Corporation is a Form 483 dated May 2, 2024, for the site in Silver Spring, Maryland.
What did FDA cite at United Therapeutics Corporation?
The regulations cited most in the observations on file for United Therapeutics Corporation are 21 CFR 211.113(b) (Control of microbiological contamination), 1 time; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.84(d)(2) (Testing and approval or rejection of components, drug product containers, and closures), 1 time.