FDA Inspection
OneBlood, Inc.OneBlood, Inc. – FDA Inspection, Nov 1, 2016
Record Details
This FDA Inspection record concerns OneBlood, Inc., with an inspection on November 1, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 678ec0af-9693-4d3e-b8b9-5ba180078ced
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 995182
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 630.10(e)(2)Additional Medical Assessment Factors
Full citation text and observation details available on the Dashboard.
Other FDA inspections of OneBlood, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| November 3, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 31, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 29, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 17, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 6, 2010 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for OneBlood, Inc.
- FDA Inspection 1222361 - 2023-11-03
- FDA Inspection 1081406 - 2019-01-31
- FDA Inspection 898276 - 2014-09-29
- FDA Inspection 795106 - 2012-08-17
- FDA Inspection 655584 - 2010-04-06
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