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FDA Inspection
•William S. Middleton Memorial Veteran's Hospital•May 8, 2025

William S. Middleton Memorial Veteran's Hospital – FDA Inspection, May 8, 2025

Record Details

This FDA Inspection record concerns William S. Middleton Memorial Veteran's Hospital, with an inspection on May 8, 2025, issued by the Minneapolis District Office, covering biologics.

Company
William S. Middleton Memorial Veteran's Hospital
Inspection Date
May 8, 2025
Product Type
Biologics
Office
Minneapolis District Office
Person
  • Irina Gaberman (FDA Associated Person)
View Company Profile

ID · b6f79cb0-159a-4907-a0b7-249efbb41154

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1269436
FDA center
Biologics
Project area
Blood and Blood Products
Outcome
Form 483 issued, view the record

FDA Citations

4
  1. 21 CFR 600.15Blood & Blood Components
  2. 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
  3. 21 CFR 606.160(a)(1)Concurrent documentation
  4. 21 CFR 606.160(b)Required records

Full citation text and observation details available on the Dashboard.

Other FDA inspections of William S. Middleton Memorial Veteran's Hospital

6
DateClassificationOfficeProject area
March 15, 2022NAICenter for Biologics Evaluation and ResearchVaccines and Allergenic Products
March 6, 2018NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
December 22, 2015NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
January 15, 2014VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
January 3, 2012VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
View all 6 other inspections on the company page
Other documents for William S. Middleton Memorial Veteran's Hospital
  • FDA Inspection 1164756 - 2022-03-15
  • FDA Inspection 1049262 - 2018-03-06
  • FDA Inspection 952971 - 2015-12-22
  • FDA Inspection 864413 - 2014-01-15
  • FDA Inspection 761415 - 2012-01-03

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