FDA Inspection
University of Utah Cell Therapy and Regenerative MedicineUniversity of Utah Cell Therapy and Regenerative Medicine – FDA Inspection, Jul 13, 2018
Record Details
This FDA Inspection record concerns University of Utah Cell Therapy and Regenerative Medicine, with an inspection on July 13, 2018, issued by the Denver District Office, covering biologics.
- Inspection Date
- July 13, 2018
- Product Type
- Biologics
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ID · 6e0fa537-cd8e-4b97-813a-d5601d977c23
Inspection Facts
- Inspection number
- 1058840
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 211.22(a)Authority lacking to review records, investigate errors
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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 |
| September 30, 2024 | VAI | 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 1229003 - 2024-09-30
- FDA Inspection 1035451 - 2017-11-15
- FDA Inspection 714335 - 2011-03-03
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