FDA Inspection
OneBlood, Inc.OneBlood, Inc. – FDA Inspection, Dec 23, 2010
Record Details
This FDA Inspection record concerns OneBlood, Inc., with an inspection on December 23, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- OneBlood, Inc.
- Inspection Date
- December 23, 2010
- Product Type
- Biologics
View Company Profile
ID · 10b8df60-583b-4450-97eb-28159e80b1bc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 703057
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.60(a)Maintain and clean equipment
- 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 |
|---|---|---|---|
| February 15, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 2, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| April 4, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 3, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 8, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for OneBlood, Inc.
- FDA Inspection 1230725 - 2024-02-15
- FDA Inspection 1088840 - 2019-05-02
- FDA Inspection 1012420 - 2017-04-04
- FDA Inspection 940840 - 2015-09-03
- FDA Inspection 822984 - 2013-03-08
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