FDA Inspection
The American National Red CrossThe American National Red Cross – FDA Inspection, Jun 27, 2019
Record Details
This FDA Inspection record concerns The American National Red Cross, with an inspection on June 27, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 046caded-3988-48ff-a4a2-c737d3fb9554
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1096443
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 640.21(g)Informed consent
- 21 CFR 640.34(c)Liquid Plasma - storage requirements
Full citation text and observation details available on the Dashboard.
Other FDA inspections of The American National Red Cross
9| Date | Classification | Office | Project area |
|---|---|---|---|
| February 9, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| January 30, 2017 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| September 18, 2015 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 15, 2014 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| June 25, 2013 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for The American National Red Cross
- FDA Inspection 1230695 - 2024-02-09
- FDA Inspection 1001329 - 2017-01-30
- FDA Inspection 942712 - 2015-09-18
- FDA Inspection 891408 - 2014-08-15
- FDA Inspection 837682 - 2013-06-25
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