FDA Inspection
OneBlood, Inc.OneBlood, Inc. – FDA Inspection, Jun 29, 2012
Record Details
This FDA Inspection record concerns OneBlood, Inc., with an inspection on June 29, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- OneBlood, Inc.
- Inspection Date
- June 29, 2012
- Product Type
- Biologics
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ID · 0e7f734c-978f-403d-a8d3-f804baabf4c5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 788568
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 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.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 2, 2021 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 12, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 4, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 19, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 9, 2010 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for OneBlood, Inc.
- FDA Inspection 1152943 - 2021-09-02
- FDA Inspection 1067887 - 2018-07-12
- FDA Inspection 985850 - 2016-08-04
- FDA Inspection 891932 - 2014-08-19
- FDA Inspection 701199 - 2010-12-09
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