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FDA Inspection
•New York Blood Center Enterprises•February 11, 2026

New York Blood Center Enterprises – FDA Inspection, Feb 11, 2026

Record Details

This FDA Inspection record concerns New York Blood Center Enterprises, with an inspection on February 11, 2026, issued by the New York District Office, covering biologics.

Company
New York Blood Center Enterprises
Inspection Date
February 11, 2026
Product Type
Biologics
Office
New York District Office
Person
  • Irina Gaberman (FDA Associated Person)
View Company Profile

ID · 773424e8-c0f3-4a89-b4fc-f157c4b9e3a8

Inspection Facts

Inspection number
1302348
FDA center
Biologics
Project area
Blood and Blood Products
Outcome
Form 483 issued

FDA Citations

3
  1. 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
  2. 21 CFR 606.160(b)Required records
  3. 21 CFR 606.60(a)Provide proper equipment to meet requirements

Full citation text and observation details available on the Dashboard.

Other FDA inspections of New York Blood Center Enterprises

7
DateClassificationOfficeProject area
November 5, 2020NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
February 7, 2018NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
December 2, 2015NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
August 20, 2014NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
September 5, 2012NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
View all 7 other inspections on the company page
Other documents for New York Blood Center Enterprises
  • FDA Inspection 1132998 - 2020-11-05
  • FDA Inspection 1040884 - 2018-02-07
  • FDA Inspection 952436 - 2015-12-02
  • FDA Inspection 892079 - 2014-08-20
  • FDA Inspection 797574 - 2012-09-05

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Contact
New York Office:
370 Jay Street 7th Floor
Brooklyn, NY 11201
Scranton Office:
Scranton Enterprise Center, Suite 217
201 Lackawanna Avenue
Scranton, PA, 18503
🇺🇸+1 917-789-5099
🇪🇺+48 532-447-507
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