FDA Inspection
United Therapeutics CorporationUnited Therapeutics Corporation – FDA Inspection, May 2, 2024
Record Details
This FDA Inspection record concerns United Therapeutics Corporation, with an inspection on May 2, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · a7dff57d-98fc-4f90-9657-0f4cf4abc4f2
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1230507
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
3- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
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Other FDA inspections of United Therapeutics Corporation
7| Date | Classification | Office | Project area |
|---|---|---|---|
| March 31, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| July 11, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| May 29, 2013 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| December 12, 2011 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| June 28, 2011 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for United Therapeutics Corporation
- FDA Inspection 1031503 - 2017-03-31
- FDA Inspection 890759 - 2014-07-11
- FDA Inspection 832855 - 2013-05-29
- FDA Inspection 756694 - 2011-12-12
- FDA Inspection 732085 - 2011-06-28
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