FDA Inspection
University of Washington Med Center - RooseveltUniversity of Washington Med Center - Roosevelt – FDA Inspection, Feb 20, 2026
Record Details
This FDA Inspection record concerns University of Washington Med Center - Roosevelt, with an inspection on February 20, 2026, issued by the Seattle District Office, covering biologics.
- Inspection Date
- February 20, 2026
- Product Type
- Biologics
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ID · 2b916acd-a966-43c0-9e2a-6936ddd6e954
Inspection Facts
- Inspection number
- 1307026
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 1271.50(a)Responsible person to determine, document
- 21 CFR 1271.55(c)Name and personal info on accompanying records
- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
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Other FDA inspections of University of Washington Med Center - Roosevelt
4| Date | Classification | Office | Project area |
|---|---|---|---|
| March 2, 2023 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 19, 2018 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| December 9, 2015 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 11, 2013 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for University of Washington Med Center - Roosevelt
- FDA Inspection 1201249 - 2023-03-02
- FDA Inspection 1056580 - 2018-06-19
- FDA Inspection 951118 - 2015-12-09
- FDA Inspection 813811 - 2013-01-11
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