FDA Inspection
Oregon Health & Science UniversityOregon Health & Science University – FDA Inspection, Jun 25, 2015
Record Details
This FDA Inspection record concerns Oregon Health & Science University, with an inspection on June 25, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- June 25, 2015
- Product Type
- Biologics
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ID · e138b08d-e33f-4d15-b0a6-a59d4d885303
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 932608
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.75(a)(1)Risk factors, clinical evidence
- 21 CFR 1271.65(b)(2)Labeled re: biohazard, risks, test results
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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 |
| May 20, 2013 | NAI | 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 832342 - 2013-05-20
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