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FDA Inspection
•New York Blood Center Enterprises•July 8, 2026

New York Blood Center Enterprises – FDA Inspection, Jul 8, 2026

Record Details

This FDA Inspection record concerns New York Blood Center Enterprises, with an inspection on July 8, 2026, issued by the New York District Office, covering biologics.

Company
New York Blood Center Enterprises
Inspection Date
July 8, 2026
Product Type
Biologics
Office
New York District Office
Person
  • Irina Gaberman (FDA Associated Person)
View Company Profile

ID · 3b7efb82-7594-4c1c-aa71-d9bfa64ec8ff

Inspection Facts

Inspection number
1325696
FDA center
Biologics
Project area
Blood and Blood Products
Outcome
Form 483 issued, view the record

FDA Citations

4
  1. 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
  2. 21 CFR 606.160(a)(1)Concurrent documentation
  3. 21 CFR 606.160(b)Required records
  4. 21 CFR 606.60(a)Maintain and clean equipment

Full citation text and observation details available on the Dashboard.

Other FDA inspections of New York Blood Center Enterprises

6
DateClassificationOfficeProject area
October 27, 2023VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
February 25, 2019VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
November 22, 2016VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
October 29, 2013VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
November 1, 2011VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
View all 6 other inspections on the company page
Other documents for New York Blood Center Enterprises
  • FDA Inspection 1221222 - 2023-10-27
  • FDA Inspection 1080716 - 2019-02-25
  • FDA Inspection 997377 - 2016-11-22
  • FDA Inspection 853530 - 2013-10-29
  • FDA Inspection 752498 - 2011-11-01

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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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