FDA Inspection
OneBlood, Inc.OneBlood, Inc. – FDA Inspection, Dec 3, 2010
Record Details
This FDA Inspection record concerns OneBlood, Inc., with an inspection on December 3, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- OneBlood, Inc.
- Inspection Date
- December 3, 2010
- Product Type
- Biologics
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ID · 608bea89-9ad9-4ea4-a60f-ed1824f62be7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 701781
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.170(a)Adverse Reaction - Investigations
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
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Other FDA inspections of OneBlood, Inc.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| February 18, 2025 | Not classified | Florida District Office | |
| May 9, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 8, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 20, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 9, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for OneBlood, Inc.
- FDA Inspection 1261631 - 2025-02-18
- FDA Inspection 1205375 - 2023-05-09
- FDA Inspection 1084709 - 2019-03-08
- FDA Inspection 999136 - 2016-12-20
- FDA Inspection 899480 - 2014-10-09
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