FDA Inspection
OneBlood, Inc.OneBlood, Inc. – FDA Inspection, Oct 20, 2015
Record Details
This FDA Inspection record concerns OneBlood, Inc., with an inspection on October 20, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- OneBlood, Inc.
- Inspection Date
- October 20, 2015
- Product Type
- Biologics
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ID · 007955fc-4aa7-4f82-9aa4-c9b362ca3b6a
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 945820
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
2- 21 CFR 606.60(a)Maintain and clean equipment
- 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
Full citation text and observation details available on the Dashboard.
Other FDA inspections of OneBlood, Inc.
6| Date | Classification | Office | Project area |
|---|---|---|---|
| May 10, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 25, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 11, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 31, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 24, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for OneBlood, Inc.
- FDA Inspection 1238917 - 2024-05-10
- FDA Inspection 1085360 - 2019-03-25
- FDA Inspection 1014163 - 2017-05-11
- FDA Inspection 872388 - 2014-03-31
- FDA Inspection 784060 - 2012-05-24
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