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FDA Inspection
•Blood Assurance Inc•September 19, 2014

Blood Assurance Inc – FDA Inspection, Sep 19, 2014

Record Details

This FDA Inspection record concerns Blood Assurance Inc, with an inspection on September 19, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Blood Assurance Inc
Inspection Date
September 19, 2014
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 78f4c9cc-58bb-4895-ba77-e4176d934477

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
897765
FDA center
Biologics
Project area
Blood and Blood Products

FDA Citations

1
  1. 21 CFR 640.3(a)(1)Donor suitability procedures not followed

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Blood Assurance Inc

6
DateClassificationOfficeProject area
October 18, 2023NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
November 20, 2019NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
March 1, 2018NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
March 3, 2016NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
January 31, 2013NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
View all 6 other inspections on the company page
Other documents for Blood Assurance Inc
  • FDA Inspection 1221066 - 2023-10-18
  • FDA Inspection 1121355 - 2019-11-20
  • FDA Inspection 1043454 - 2018-03-01
  • FDA Inspection 961100 - 2016-03-03
  • FDA Inspection 816546 - 2013-01-31

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Contact
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Brooklyn, NY 11201
Scranton Office:
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Scranton, PA, 18503
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