FDA Inspection
Oklahoma Blood InstituteOklahoma Blood Institute – FDA Inspection, Jun 7, 2019
Record Details
This FDA Inspection record concerns Oklahoma Blood Institute, with an inspection on June 7, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 8799c476-b54f-4568-ae8a-d44019f898f3
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1093994
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 610.40(b)One or more approved screening tests
- 21 CFR 606.60(a)Equipment observed, standardized, calibrated
- 21 CFR 606.145(d)Infection in bloodstream
- 21 CFR 606.145(a)Control risk of contamination
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 630.10(e)(2)Additional Medical Assessment Factors
- 21 CFR 606.160(a)(1)Concurrent documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Oklahoma Blood Institute
7| Date | Classification | Office | Project area |
|---|---|---|---|
| August 20, 2024 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| June 20, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 20, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 7, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 11, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Oklahoma Blood Institute
- FDA Inspection 1231637 - 2024-08-20
- FDA Inspection 1023507 - 2017-06-20
- FDA Inspection 945662 - 2015-08-20
- FDA Inspection 876145 - 2014-05-07
- FDA Inspection 810435 - 2012-10-11
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