FDA Inspection
University of Washington Med Center - RooseveltUniversity of Washington Med Center - Roosevelt – FDA Inspection, Jun 19, 2018
Record Details
This FDA Inspection record concerns University of Washington Med Center - Roosevelt, with an inspection on June 19, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 19, 2018
- Product Type
- Biologics
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ID · 264e965e-4c05-4ff4-b03f-6ef31e69f474
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1056580
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 1271.50(b)(1)Donor screening standards
- 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
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Other FDA inspections of University of Washington Med Center - Roosevelt
4| Date | Classification | Office | Project area |
|---|---|---|---|
| February 20, 2026 | Not classified | Seattle District Office | Human Cellular, Tissue, and Gene Therapies |
| March 2, 2023 | NAI | 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 1307026 - 2026-02-20
- FDA Inspection 1201249 - 2023-03-02
- FDA Inspection 951118 - 2015-12-09
- FDA Inspection 813811 - 2013-01-11
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