FDA Inspection
Oregon Health & Science UniversityOregon Health & Science University – FDA Inspection, May 27, 2011
Record Details
This FDA Inspection record concerns Oregon Health & Science University, with an inspection on May 27, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- May 27, 2011
- Product Type
- Biologics
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ID · 27e29e8e-94b3-401e-9a23-9bcb5c57a46f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 727977
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
6- 21 CFR 1271.55(d)(2)Accurate, indelible, legible
- 21 CFR 1271.50(b)(2)Donor testing not negative for CD agents
- 21 CFR 1271.90(c)(1)Autologous use only--labeling
- 21 CFR 1271.90(c)Eligibility not required--warning labels
- 21 CFR 1271.75(e)Abbreviated procedure
- 21 CFR 1271.55(b)(4)Reasons for ineligibility on summary
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Other FDA inspections of Oregon Health & Science University
8| Date | Classification | Office | Project area |
|---|---|---|---|
| June 26, 2025 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| March 8, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 17, 2019 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| September 14, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 25, 2015 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Oregon Health & Science University
- FDA Inspection 1275644 - 2025-06-26
- FDA Inspection 1164356 - 2022-03-08
- FDA Inspection 1102438 - 2019-09-17
- FDA Inspection 983623 - 2016-09-14
- FDA Inspection 932608 - 2015-06-25
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