FDA Inspection 1229003 — University Of Utah Cell Therapy And Regenerative Medicine
The FDA completed an inspection of University Of Utah Cell Therapy And Regenerative Medicine on Sep 30, 2024 in Salt Lake City, UT. 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 30, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Salt Lake City, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12435 | 21 CFR 1271.270(a) | Records maintained concurrently |
| 12453 | 21 CFR 1271.290(e) | Documenting disposition of each HCT/P |