FDA Inspection
OneBlood, Inc.OneBlood, Inc. – FDA Inspection, Aug 10, 2009
Record Details
This FDA Inspection record concerns OneBlood, Inc., with an inspection on August 10, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- OneBlood, Inc.
- Inspection Date
- August 10, 2009
- Product Type
- Biologics
View Company Profile
ID · 92aa26f0-9720-48cc-8681-34b396974da9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 607300
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.160(b)Required records
- 21 CFR 606.170(a)Adverse Reaction- Reports of Investigations
- 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 |
|---|---|---|---|
| April 30, 2025 | Not classified | Florida District Office | |
| April 28, 2023 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 28, 2019 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 26, 2017 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 27, 2015 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for OneBlood, Inc.
- FDA Inspection 1268702 - 2025-04-30
- FDA Inspection 1204018 - 2023-04-28
- FDA Inspection 1099888 - 2019-06-28
- FDA Inspection 1020009 - 2017-07-26
- FDA Inspection 940684 - 2015-08-27
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