FDA Inspection
OneBlood Inc.OneBlood Inc. – FDA Inspection, Sep 9, 2010
Record Details
This FDA Inspection record concerns OneBlood Inc., with an inspection on September 9, 2010, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- OneBlood Inc.
- Inspection Date
- September 9, 2010
- Product Type
- Biologics
View Company Profile
ID · b31b2904-056b-4a3b-ad80-d30d64ffcc10
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 677617
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
1- 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 |
|---|---|---|---|
| August 18, 2022 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 2, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 19, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 16, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 30, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for OneBlood Inc.
- FDA Inspection 1178051 - 2022-08-18
- FDA Inspection 1069660 - 2018-10-02
- FDA Inspection 987160 - 2016-07-19
- FDA Inspection 887401 - 2014-07-16
- FDA Inspection 796636 - 2012-08-30
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