FDA Inspection
OneBlood, IncOneBlood, Inc – FDA Inspection, May 11, 2012
Record Details
This FDA Inspection record concerns OneBlood, Inc, with an inspection on May 11, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- OneBlood, Inc
- Inspection Date
- May 11, 2012
- Product Type
- Biologics
View Company Profile
ID · b3213719-35e9-4260-ab58-8fd7176f2ef1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 784663
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 640.4(h)Storage temperatures after collection
- 21 CFR 640.3(a)(1)Donor suitability procedures not followed
- 21 CFR 640.11(a)General requirements - storage
Full citation text and observation details available on the Dashboard.
Other FDA inspections of OneBlood, Inc
6| Date | Classification | Office | Project area |
|---|---|---|---|
| February 20, 2025 | Not classified | Florida District Office | |
| September 1, 2021 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 20, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| May 2, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 13, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for OneBlood, Inc
- FDA Inspection 1262087 - 2025-02-20
- FDA Inspection 1152583 - 2021-09-01
- FDA Inspection 1051870 - 2018-03-20
- FDA Inspection 972178 - 2016-05-02
- FDA Inspection 883106 - 2014-06-13
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