FDA Inspection
Oregon Health & Science UniversityOregon Health & Science University – FDA Inspection, Jul 2, 2009
Record Details
This FDA Inspection record concerns Oregon Health & Science University, with an inspection on July 2, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- July 2, 2009
- Product Type
- Biologics
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ID · a26eba66-e770-4816-aaac-6647e792a325
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 596066
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
4- 21 CFR 1271.200(a)Cleaned, sanitized per established schedules
- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 1271.160(c)Quality audits performed periodically
- 21 CFR 606.160(a)(1)Person performing, test results, interpretation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Oregon Health & Science University
7| Date | Classification | Office | Project area |
|---|---|---|---|
| August 9, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 28, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 10, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 12, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 25, 2010 | VAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for Oregon Health & Science University
- FDA Inspection 1178821 - 2022-08-09
- FDA Inspection 961547 - 2016-01-28
- FDA Inspection 861795 - 2014-01-10
- FDA Inspection 762869 - 2012-01-12
- FDA Inspection 695173 - 2010-10-25
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