FDA Inspection
Department of Defense - ArmyDepartment of Defense - Army – FDA Inspection, Jul 17, 2018
Record Details
This FDA Inspection record concerns Department of Defense - Army, with an inspection on July 17, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.
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ID · 6846b724-d89f-493b-b6c9-95be789e0d38
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1059131
- FDA center
- Biologics
- Project area
- Blood and Blood Products
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 610.41Donor Deferral
- 21 CFR 606.65(e)Following manufacturer"s instructions
- 21 CFR 606.65(e)Following manufacturer's instructions
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Other FDA inspections of Department of Defense - Army
5| Date | Classification | Office | Project area |
|---|---|---|---|
| March 21, 2025 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 28, 2016 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| March 11, 2014 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| August 20, 2012 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| July 26, 2010 | VAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
Other documents for Department of Defense - Army
- FDA Inspection 1266407 - 2025-03-21
- FDA Inspection 964885 - 2016-03-28
- FDA Inspection 869741 - 2014-03-11
- FDA Inspection 795522 - 2012-08-20
- FDA Inspection 678028 - 2010-07-26
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