FDA Inspection
OneBlood, Inc.OneBlood, Inc. – FDA Inspection, Aug 5, 2011
Record Details
This FDA Inspection record concerns OneBlood, Inc., with an inspection on August 5, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Company
- OneBlood, Inc.
- Inspection Date
- August 5, 2011
- Product Type
- Biologics
View Company Profile
ID · 2bacfc6b-e9dc-40d4-bd15-84d893a8c6dd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 738690
- FDA center
- Biologics
- Project area
- Blood and Blood Products
FDA Citations
3- 21 CFR 606.60(b)Equipment calibration frequency
- 21 CFR 601.12(b)Major changes to an approved application
- 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.
7| Date | Classification | Office | Project area |
|---|---|---|---|
| April 23, 2025 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 20, 2021 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 20, 2018 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 25, 2016 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 8, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for OneBlood, Inc.
- FDA Inspection 1268367 - 2025-04-23
- FDA Inspection 1147262 - 2021-07-20
- FDA Inspection 1067759 - 2018-06-20
- FDA Inspection 971832 - 2016-03-25
- FDA Inspection 890522 - 2014-08-08
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.