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FDA Inspection
•Washington Hospital Center Transfusion Service•April 6, 2018

Washington Hospital Center Transfusion Service – FDA Inspection, Apr 6, 2018

Record Details

This FDA Inspection record concerns Washington Hospital Center Transfusion Service, with an inspection on April 6, 2018, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Washington Hospital Center Transfusion Service
Inspection Date
April 6, 2018
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
People
  • Amanda B Vega (Issuing Officer)
  • La-tasha M. Gunter (Issuing Officer)
View Company Profile

ID · 3985fef5-b2c3-4771-920f-5c5ddf1cafe5

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1047535
FDA center
Biologics
Project area
Blood and Blood Products
Outcome
Form 483 issued

FDA Citations

3
  1. 21 CFR 606.100(c)Thorough investigations
  2. 21 CFR 606.171Biological product deviation report
  3. 21 CFR 211.22(d)Procedures not in writing, fully followed

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Washington Hospital Center Transfusion Service

9
DateClassificationOfficeProject area
November 16, 2023NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
September 20, 2022NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
March 8, 2016NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
June 24, 2014NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
January 28, 2013NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
View all 9 other inspections on the company page
Other documents for Washington Hospital Center Transfusion Service
  • FDA Inspection 1224426 - 2023-11-16
  • FDA Inspection 1181203 - 2022-09-20
  • FDA Inspection 964119 - 2016-03-08
  • FDA Inspection 887633 - 2014-06-24
  • FDA Inspection 816379 - 2013-01-28

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