FDA Inspection 1260739 — United Therapeutic Corporation
The FDA completed an inspection of United Therapeutic Corporation on Feb 11, 2025 in Beltsville, MD. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 11, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Beltsville, MD (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1794 | 21 CFR 211.80(d) | Disposition recorded by lot identification |
| 4307 | 21 CFR 211.80(d) | Status of Each Lot Identified |