FDA Inspection
OneBlood, Inc.OneBlood, Inc. – FDA Inspection, Feb 21, 2013
Record Details
This FDA Inspection record concerns OneBlood, Inc., with an inspection on February 21, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- OneBlood, Inc.
- Inspection Date
- February 21, 2013
- Product Type
- Biologics
View Company Profile
ID · 0d595271-fd66-4bf3-8b3d-ab8e9670e092
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 819652
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
4- 21 CFR 600.10(b)Personnel capabilities
- 21 CFR 606.100(c)Thorough investigations
- 21 CFR 606.20(b)Qualifications of responsible personnel
- 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 |
|---|---|---|---|
| January 16, 2025 | Not classified | Florida District Office | |
| April 20, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 11, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 5, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| February 5, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for OneBlood, Inc.
- FDA Inspection 1258573 - 2025-01-16
- FDA Inspection 1203286 - 2023-04-20
- FDA Inspection 1095570 - 2019-06-11
- FDA Inspection 995158 - 2016-12-05
- FDA Inspection 912716 - 2015-02-05
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