FDA Inspection
We Are BloodWe Are Blood – FDA Inspection, Sep 20, 2018
Record Details
This FDA Inspection record concerns We Are Blood, with an inspection on September 20, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
View Company Profile
ID · 29a474ac-d911-416d-b05f-b54466ce15f5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1066784
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 600.15Blood & Blood Components
- 21 CFR 606.160(a)(1)Concurrent documentation
- 21 CFR 640.11(a)General requirements - storage
- 21 CFR 640.21(g)Informed consent
Full citation text and observation details available on the Dashboard.
Other FDA inspections of We Are Blood
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 2, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 27, 2016 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| July 11, 2014 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
| January 17, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| December 2, 2010 | NAI | Center for Biologics Evaluation and Research | Human Cellular, Tissue, and Gene Therapies |
Other documents for We Are Blood
- FDA Inspection 1230829 - 2024-08-02
- FDA Inspection 981344 - 2016-07-27
- FDA Inspection 887056 - 2014-07-11
- FDA Inspection 815175 - 2013-01-17
- FDA Inspection 700339 - 2010-12-02
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.