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FDA Inspection
•Veterans Administration Northern IN Healthcare System•April 8, 2011

Veterans Administration Northern IN Healthcare System – FDA Inspection, Apr 8, 2011

Record Details

This FDA Inspection record concerns Veterans Administration Northern IN Healthcare System, with an inspection on April 8, 2011, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Veterans Administration Northern IN Healthcare System
Inspection Date
April 8, 2011
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · ad65364d-82cf-40e1-b856-6e957abc2e16

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
719338
FDA center
Biologics
Project area
Blood and Blood Products

FDA Citations

3
  1. 21 CFR 606.160(a)(1)Person performing, test results, interpretation
  2. 21 CFR 606.20(b)Qualifications of responsible personnel
  3. 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 Veterans Administration Northern IN Healthcare System

4
DateClassificationOfficeProject area
September 10, 2019NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
April 12, 2017NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
June 9, 2015NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
March 12, 2013NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
Other documents for Veterans Administration Northern IN Healthcare System
  • FDA Inspection 1107095 - 2019-09-10
  • FDA Inspection 1008328 - 2017-04-12
  • FDA Inspection 929620 - 2015-06-09
  • FDA Inspection 823162 - 2013-03-12

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