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New York Blood Center, Inc. FDA Inspection Record

FEI 2276020 · Inspections, Form 483s, warning letters and import refusals

New York Blood Center, Inc. is an FDA-inspected facility (FEI 2276020) located in New Brunswick, NJ, US. RegDataLab tracks 7 FDA inspections at this facility.

What FDA found at this site

Latest inspection: Dec 19, 2022: No Action Indicated (NAI)
Inspections on record: 7 (7 NAI)
Last OAI inspection: None on record
Warning letters: None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
Recalls as the recalling firm: 25, latest Sep 6, 2019

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Newest first. Citations are the inspector observations FDA publishes for the inspection.

Date	Result	What FDA cited
Dec 19, 2022	No Action Indicated (NAI)	No citations listed
Jun 24, 2019	No Action Indicated (NAI)	No citations listed
Apr 25, 2017	No Action Indicated (NAI)	No citations listed
Nov 7, 2014	No Action Indicated (NAI)	No citations listed
May 10, 2013	No Action Indicated (NAI)	No citations listed
Oct 19, 2011	No Action Indicated (NAI)	No citations listed
Feb 4, 2010	No Action Indicated (NAI)	No citations listed

Recalls

Showing the 10 most recent of 25 recalls. Recalls FDA's Enforcement Report lists with this FEI as the recalling firm. The recalling firm is not always the site that made the product. Search FDA's Enforcement Report by recall number.

Date	Class	Recall	Product and reason
Sep 6, 2019	Class II	B-0061-2020	Blood and Blood Products for Reprocessing and 1 more product Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Aug 30, 2019	Class II	B-0001-2020	Blood and Blood Products for Reprocessing and 1 more product Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Jun 29, 2018	Class II	B-0726-2018	Red Blood Cells, Leukocytes Reduced and 1 more product Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Jun 7, 2018	Class II	B-0696-2018	Red Blood Cells, Leukocytes Reduced and 1 more product Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
May 16, 2018	Class II	B-0702-2018	Red Blood Cells, Leukocytes Reduced, Irradiated and 2 more products Blood products, collected from an ineligible donor, were distributed.
Feb 7, 2018	Class II	B-0444-2018	Red Blood Cells, Leukocytes Reduced and 1 more product Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Jan 23, 2018	Class II	B-0394-2018	Red Blood Cells, Leukocytes Reduced Blood products, collected from a donor who was previously deferred, were distributed.
Jan 2, 2018	Class II	B-0343-2018	Red Blood Cells, Leukocytes Reduced and 1 more product Blood products collected from a donor for whom donor suitability was not adequately determined, were distributed.
Dec 21, 2017	Class II	B-0363-2018	Red Blood Cells, Leukocytes Reduced and 1 more product Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Dec 8, 2017	Class II	B-0329-2018	Blood and Blood Products for Reprocessing and 2 more products Blood products, which was collected from a donor in which donor suitability was not adequately determined, were distributed.

FDA record score

18 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 14, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

25 records behind this number

Record	Date	Points x age weight	Adds
Class II recall B-0061-2020, this FEI as the recalling firm	Sep 6, 2019	4 x 0.25	1
Class II recall B-0001-2020, this FEI as the recalling firm	Aug 30, 2019	4 x 0.25	1
Class II recall B-0726-2018, this FEI as the recalling firm	Jun 29, 2018	4 x 0.25	1
Class II recall B-0696-2018, this FEI as the recalling firm	Jun 7, 2018	4 x 0.25	1
Class II recall B-0702-2018, this FEI as the recalling firm	May 16, 2018	4 x 0.25	1
Class II recall B-0444-2018, this FEI as the recalling firm	Feb 7, 2018	4 x 0.25	1
Class II recall B-0394-2018, this FEI as the recalling firm	Jan 23, 2018	4 x 0.25	1
Class II recall B-0343-2018, this FEI as the recalling firm	Jan 2, 2018	4 x 0.25	1
Class II recall B-0363-2018, this FEI as the recalling firm	Dec 21, 2017	4 x 0.25	1
Class II recall B-0329-2018, this FEI as the recalling firm	Dec 8, 2017	4 x 0.25	1
Class II recall B-0133-2018, this FEI as the recalling firm	Oct 4, 2017	4 x 0.25	1
Class II recall B-0143-2018, this FEI as the recalling firm	Sep 25, 2017	4 x 0.25	1
Class II recall B-0053-2018, this FEI as the recalling firm	Aug 23, 2017	4 x 0.25	1
Class II recall B-0755-2017, this FEI as the recalling firm	Jun 20, 2017	4 x 0.25	1
Class II recall B-0898-2017, this FEI as the recalling firm	Jun 19, 2017	4 x 0.25	1
Class II recall B-0694-2017, this FEI as the recalling firm	May 10, 2017	4 x 0.25	1
Class II recall B-0673-2017, this FEI as the recalling firm	May 2, 2017	4 x 0.25	1
Class II recall B-0383-2017, this FEI as the recalling firm	Jan 31, 2017	4 x 0.25	1
Class II recall B-1473-13, this FEI as the recalling firm	Feb 19, 2013	10 years or older, so it adds no points	0
Class II recall B-1623-08, this FEI as the recalling firm	Apr 11, 2007	10 years or older, so it adds no points	0
Class II recall B-0818-7, this FEI as the recalling firm	Feb 8, 2006	10 years or older, so it adds no points	0
Class II recall B-0819-7, this FEI as the recalling firm	Dec 4, 2005	10 years or older, so it adds no points	0
Class II recall B-2255-5, this FEI as the recalling firm	Feb 24, 2005	10 years or older, so it adds no points	0
Class II recall B-0468-3, this FEI as the recalling firm	Jun 5, 2002	10 years or older, so it adds no points	0
Class II recall B-0503-3, this FEI as the recalling firm	Nov 14, 2001	10 years or older, so it adds no points	0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
Records	Last refreshed	Source as of	Status
Inspections	Nov 14, 2026	Newest record Nov 5, 2026	Current
Inspection citations	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions (warning letters, injunctions and other action types)	Nov 2, 2026	Newest record Oct 29, 2026	Current
Warning letter text	Nov 14, 2026	Newest record Nov 10, 2026	Current
Recalls (Enforcement Report)	Nov 14, 2026	Newest record Nov 11, 2026	Current
Form 483s and inspection documents	Nov 13, 2026	Newest record Nov 12, 2026	Current
Import refusals	Nov 2, 2026	Newest record Oct 22, 2026	Current

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Facility details

Company: New York Blood Center, Inc.
Location: New Brunswick, NJ (US)
Source: inspections