FDA Inspection
University of Utah Cell Therapy and Regenerative MedicineUniversity of Utah Cell Therapy and Regenerative Medicine – FDA Inspection, Sep 30, 2024
Record Details
This FDA Inspection record concerns University of Utah Cell Therapy and Regenerative Medicine, with an inspection on September 30, 2024, issued by the Denver District Office, covering biologics.
- Inspection Date
- September 30, 2024
- Product Type
- Biologics
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ID · 0c1d4c00-2750-4476-9d09-f6de4ff56463
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1229003
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.290(e)Documenting disposition of each HCT/P
- 21 CFR 1271.270(a)Records maintained concurrently
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Other FDA inspections of University of Utah Cell Therapy and Regenerative Medicine
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 11, 2026 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 13, 2018 | Not classified | Denver District Office | Human Cellular, Tissue, and Gene Therapies |
| November 15, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 3, 2011 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for University of Utah Cell Therapy and Regenerative Medicine
- FDA Inspection 1336336 - 2026-09-11
- FDA Inspection 1058840 - 2018-07-13
- FDA Inspection 1035451 - 2017-11-15
- FDA Inspection 714335 - 2011-03-03
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