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FDA Inspection
•Department of Defense - Army•February 1, 2017

Department of Defense - Army – FDA Inspection, Feb 1, 2017

Record Details

This FDA Inspection record concerns Department of Defense - Army, with an inspection on February 1, 2017, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Department of Defense - Army
Inspection Date
February 1, 2017
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
Person
  • Maira P. Brading (Company Rep)
View Company Profile

ID · cd3b8680-7d71-4d57-b361-0eac9d5382fe

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1004242
FDA center
Biologics
Project area
Blood and Blood Products
Outcome
Form 483 issued

FDA Citations

1
  1. 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 Department of Defense - Army

6
DateClassificationOfficeProject area
January 22, 2025NAIBlood and Blood Products
August 23, 2019NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
February 12, 2015VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
August 13, 2013NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
September 7, 2011NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
View all 6 other inspections on the company page
Other documents for Department of Defense - Army
  • FDA Inspection 1259848 - 2025-01-22
  • FDA Inspection 1101865 - 2019-08-23
  • FDA Inspection 914406 - 2015-02-12
  • FDA Inspection 847590 - 2013-08-13
  • FDA Inspection 748945 - 2011-09-07

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