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New York Blood Center Enterprises FDA Inspection Record

FEI 2470902 · Inspections, Form 483s, warning letters and import refusals

New York Blood Center Enterprises is an FDA-inspected facility (FEI 2470902) located in Westbury, NY, US. RegDataLab tracks 6 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Oct 27, 2023: Voluntary Action Indicated (VAI)
Inspections on record
6 (6 VAI)
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
49, latest Sep 27, 2024

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.

DateResultWhat FDA cited
Oct 27, 2023Voluntary Action Indicated (VAI)Written calibration / inspection records not kept (21 CFR 211.68(a))
Required records (21 CFR 606.160(b))
Following manufacturer's instructions (21 CFR 606.65(e))
Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b))
Feb 25, 2019Voluntary Action Indicated (VAI)Concurrent documentation (21 CFR 606.160(a)(1))
Required records (21 CFR 606.160(b))
Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b))
Biological product deviation report (21 CFR 606.171)
and 1 more
Nov 22, 2016Voluntary Action Indicated (VAI)No citations listed
Oct 29, 2013Voluntary Action Indicated (VAI)Equipment calibration frequency (21 CFR 606.60(b))
Concurrent documentation (21 CFR 606.160(a)(1))
Required records (21 CFR 606.160(b))
Complete test data included in records (21 CFR 211.194(a))
and 3 more
Nov 1, 2011Voluntary Action Indicated (VAI)Legibility and indelibility (21 CFR 606.160(a)(1))
Deviations from laboratory control requirements (21 CFR 211.160(a))
Scientifically sound laboratory controls (21 CFR 211.160(b))
Maintain and clean equipment (21 CFR 606.60(a))
and 4 more
Sep 4, 2009Voluntary Action Indicated (VAI)SOPs not followed / documented (21 CFR 211.100(b))
Documentation (21 CFR 820.75(a))
Second person sign off (21 CFR 211.194(a)(8))

Recalls

Showing the 10 most recent of 49 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.

DateClassRecallProduct and reason
Sep 27, 2024Class IIB-0122-2025Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated and 1 more product
Leukoreduced Red Blood Cells Products, which were labeled as irradiated but were not irradiated, were distributed.
Jun 6, 2024Class IIB-0478-2024Apheresis Platelets, Leukocytes Reduced
Leukoreduced Apheresis Platelets, which were labeled as leukocytes reduced but failed the monthly QC residual white blood cell count, were…
Feb 23, 2024Class IIIB-0417-2024Apheresis Platelets, Leukocytes Reduced
Leukoreduced Apheresis Platelets, labeled with an incorrect volume, were distributed.
Aug 4, 2023Class IIB-0015-2024Apheresis Platelets, Leukocytes Reduced
Leukoreduced Apheresis Platelets, for which pathogen reduction was performed incorrectly, were distributed.
Feb 1, 2023Class IIB-0320-2023Red Blood Cells, Leukocytes Reduced, Irradiated
Leukoreduced Red Blood Cell product, collected from a donor who had previously tested reactive for Hepatitis C (HCV), was distributed.
Feb 1, 2023Class IIB-0474-2023Red Blood Cells, Leukocytes Reduced and 1 more product
Blood products, collected from a donor in which the donor was not tested for Chagas, were distributed.
Dec 7, 2020Class IIB-0162-2021Red Blood Cells, Leukocytes Reduced, Irradiated
Red Blood Cell product, for which donor Screening, deferral screening not done or incorrectly performed, including incorrect ID used during…
Jul 9, 2020Class IIIB-0663-2020Apheresis Platelets, Leukocytes Reduced and 1 more product
Plateletpheresis products, exposed to unacceptable temperatures during storage, were distributed.
Jan 30, 2020Class IIB-0417-2020Red Blood Cells, Leukocytes Reduced and 1 more product
Blood products, collected from a donor whose donor eligibility was incomplete, were distributed.
Nov 4, 2019Class IIB-0130-2020Pooled Cryoprecipitated AHF and 2 more products
Blood products, for which donor eligibility screening was incorrectly performed, were distributed.

FDA record score

47 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 15, 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.

50 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIOct 27, 20236 x 0.63.6
Class II recall B-0122-2025, this FEI as the recalling firmSep 27, 20244 x 0.62.4
Class II recall B-0478-2024, this FEI as the recalling firmJun 6, 20244 x 0.62.4
Class II recall B-0015-2024, this FEI as the recalling firmAug 4, 20234 x 0.62.4
Class II recall B-0320-2023, this FEI as the recalling firmFeb 1, 20234 x 0.62.4
Class II recall B-0474-2023, this FEI as the recalling firmFeb 1, 20234 x 0.62.4
Inspection classified VAIFeb 25, 20196 x 0.251.5
Inspection classified VAINov 22, 20166 x 0.251.5
Class II recall B-0162-2021, this FEI as the recalling firmDec 7, 20204 x 0.251
Class II recall B-0417-2020, this FEI as the recalling firmJan 30, 20204 x 0.251
Class II recall B-0130-2020, this FEI as the recalling firmNov 4, 20194 x 0.251
Class II recall B-0631-2019, this FEI as the recalling firmApr 15, 20194 x 0.251
Class II recall B-0598-2019, this FEI as the recalling firmMar 25, 20194 x 0.251
Class II recall B-0472-2019, this FEI as the recalling firmMar 19, 20194 x 0.251
Class II recall B-0475-2019, this FEI as the recalling firmFeb 15, 20194 x 0.251
Class II recall B-0501-2019, this FEI as the recalling firmFeb 14, 20194 x 0.251
Class II recall B-0291-2019, this FEI as the recalling firmDec 3, 20184 x 0.251
Class II recall B-0267-2019, this FEI as the recalling firmNov 9, 20184 x 0.251
Class II recall B-0298-2019, this FEI as the recalling firmNov 9, 20184 x 0.251
Class II recall B-0233-2019, this FEI as the recalling firmOct 29, 20184 x 0.251
Class II recall B-0170-2019, this FEI as the recalling firmOct 16, 20184 x 0.251
Class II recall B-0795-2018, this FEI as the recalling firmJul 23, 20184 x 0.251
Class II recall B-0498-2018, this FEI as the recalling firmFeb 14, 20184 x 0.251
Class II recall B-0462-2018, this FEI as the recalling firmFeb 2, 20184 x 0.251
Class II recall B-0367-2018, this FEI as the recalling firmDec 4, 20174 x 0.251
Class II recall B-0106-2018, this FEI as the recalling firmOct 5, 20174 x 0.251
Class II recall B-0058-2018, this FEI as the recalling firmSep 18, 20174 x 0.251
Class II recall B-0870-2017, this FEI as the recalling firmJul 17, 20174 x 0.251
Class II recall B-0807-2017, this FEI as the recalling firmMay 30, 20174 x 0.251
Class II recall B-0696-2017, this FEI as the recalling firmMay 8, 20174 x 0.251
Class II recall B-0612-2017, this FEI as the recalling firmMar 28, 20174 x 0.251
Class II recall B-0573-2017, this FEI as the recalling firmMar 20, 20174 x 0.251
Class II recall B-0478-2017, this FEI as the recalling firmJan 31, 20174 x 0.251
Class II recall B-0394-2017, this FEI as the recalling firmJan 6, 20174 x 0.251
Class II recall B-0331-2017, this FEI as the recalling firmDec 2, 20164 x 0.251
Class II recall B-0309-2017, this FEI as the recalling firmNov 23, 20164 x 0.251
Class II recall B-0624-16, this FEI as the recalling firmMay 19, 201610 years or older, so it adds no points0
Class II recall B-0573-16, this FEI as the recalling firmApr 14, 201610 years or older, so it adds no points0
Class II recall B-0081-16, this FEI as the recalling firmSep 15, 201510 years or older, so it adds no points0
Inspection classified VAIOct 29, 201310 years or older, so it adds no points0
Class II recall B-0181-14, this FEI as the recalling firmOct 8, 201310 years or older, so it adds no points0
Class II recall B-0179-14, this FEI as the recalling firmSep 30, 201310 years or older, so it adds no points0
Class II recall B-0610-13, this FEI as the recalling firmSep 27, 201210 years or older, so it adds no points0
Class II recall B-0104-13, this FEI as the recalling firmJul 31, 201210 years or older, so it adds no points0
Class II recall B-0035-13, this FEI as the recalling firmJul 27, 201210 years or older, so it adds no points0
Inspection classified VAINov 1, 201110 years or older, so it adds no points0
Class II recall B-0514-13, this FEI as the recalling firmOct 7, 201110 years or older, so it adds no points0
Class II recall B-2138-12, this FEI as the recalling firmJun 8, 201110 years or older, so it adds no points0
Inspection classified VAISep 4, 200910 years or older, so it adds no points0
Class II recall B-1562-13, this FEI as the recalling firmJan 21, 200810 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 14, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 14, 2026Newest record Nov 5, 2026Current
Compliance actions (warning letters, injunctions and other action types)Nov 2, 2026Newest record Oct 29, 2026Current
Warning letter textNov 14, 2026Newest record Nov 10, 2026Current
Recalls (Enforcement Report)Nov 14, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 2, 2026Newest record Oct 22, 2026Current

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Facility details

Company
New York Blood Center Enterprises
Location
Westbury, NY (US)
Source
inspections

FDA data resources

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.