Home / Facilities / 1970753

Innovative Blood Resources, A Division Of New York Blood Center, Inc. FDA Inspection Record

FEI 1970753 · Inspections, Form 483s, warning letters and import refusals

Innovative Blood Resources, A Division Of New York Blood Center, Inc. is an FDA-inspected facility (FEI 1970753) located in Lincoln, NE, US. RegDataLab tracks 8 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Oct 23, 2024: No Action Indicated (NAI)
Inspections on record
8 (5 VAI, 3 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
43, latest Oct 30, 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 23, 2024No Action Indicated (NAI)No citations listed
May 31, 2019No Action Indicated (NAI)No citations listed
May 3, 2017No Action Indicated (NAI)No citations listed
Apr 17, 2015Voluntary Action Indicated (VAI)No citations listed
Jul 23, 2012Voluntary Action Indicated (VAI)No citations listed
Sep 2, 2011Voluntary Action Indicated (VAI)Thorough investigations (21 CFR 606.100(c))
Oct 1, 2010Voluntary Action Indicated (VAI)No citations listed
Jun 26, 2009Voluntary Action Indicated (VAI)Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b))

Recalls

Showing the 10 most recent of 43 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
Oct 30, 2024Class IIB-0121-2025Apheresis Platelets, Leukocytes Reduced
Leukoreduced Apheresis Platelets, which were labeled as leukocytes reduced but were not tested to verify white blood cell count, were…
Feb 13, 2024Class IIB-0260-2024Red Blood Cells, Irradiated
Red Blood Cell products that were inadequately irradiated, were distributed.
Jul 6, 2023Class IIIB-0601-2023Red Blood Cells
Misbranded Red Blood Cell products were distributed.
Dec 29, 2022Class IIIB-0238-2023Apheresis Platelets, Leukocytes Reduced
Leukoreduced Apheresis Platelets, which were labeled with an incorrect volume, were distributed.
Feb 10, 2022Class IIB-0309-2022Apheresis Platelets, Leukocytes Reduced
Leukoreduced Apheresis Platelets, collected in a manner that compromises the sterility of the collection system, were distributed.
May 6, 2020Class IIB-0077-2021Red Blood Cells, Leukocytes Reduced and 1 more product
Blood products, collected from a donor who previously tested positive for the antibody to Hepatitis B core Antigen on more than one occasion…
Dec 20, 2019Class IIIB-0303-2020Platelets, Pathogen Reduced
Plateletpheresis products, lacking assurance of proper storage and shipment temperatures, were distributed.
Dec 17, 2019Class IIIB-0329-2020Apheresis Platelets, Leukocytes Reduced
Blood product, which was labeled with an incorrect volume, was distributed.
Oct 31, 2016Class IIB-0218-2017Red Blood Cells, Leukocytes Reduced
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.
Apr 14, 2016Class IIB-0556-16Red Blood Cells, Leukocytes Reduced
Blood product, collected from a donor who traveled to a malarial endemic area, was distributed.

FDA record score

8 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.

41 records behind this number
RecordDatePoints x age weightAdds
Class II recall B-0121-2025, this FEI as the recalling firmOct 30, 20244 x 0.62.4
Class II recall B-0260-2024, this FEI as the recalling firmFeb 13, 20244 x 0.62.4
Class II recall B-0309-2022, this FEI as the recalling firmFeb 10, 20224 x 0.62.4
Class II recall B-0077-2021, this FEI as the recalling firmMay 6, 20204 x 0.251
Class II recall B-0218-2017, this FEI as the recalling firmOct 31, 201610 years or older, so it adds no points0
Class II recall B-0556-16, this FEI as the recalling firmApr 14, 201610 years or older, so it adds no points0
Class II recall B-0466-16, this FEI as the recalling firmMar 7, 201610 years or older, so it adds no points0
Class II recall B-0494-16, this FEI as the recalling firmMar 7, 201610 years or older, so it adds no points0
Class II recall B-0363-16, this FEI as the recalling firmJan 21, 201610 years or older, so it adds no points0
Inspection classified VAIApr 17, 201510 years or older, so it adds no points0
Class II recall B-0212-14, this FEI as the recalling firmOct 3, 201310 years or older, so it adds no points0
Class II recall B-2533-13, this FEI as the recalling firmJul 8, 201310 years or older, so it adds no points0
Class II recall B-2220-13, this FEI as the recalling firmMay 14, 201310 years or older, so it adds no points0
Class II recall B-1435-13, this FEI as the recalling firmJan 28, 201310 years or older, so it adds no points0
Class II recall B-0444-13, this FEI as the recalling firmSep 18, 201210 years or older, so it adds no points0
Inspection classified VAIJul 23, 201210 years or older, so it adds no points0
Class II recall B-2424-12, this FEI as the recalling firmJun 7, 201210 years or older, so it adds no points0
Inspection classified VAISep 2, 201110 years or older, so it adds no points0
Inspection classified VAIOct 1, 201010 years or older, so it adds no points0
Inspection classified VAIJun 26, 200910 years or older, so it adds no points0
Class II recall B-2066-12, this FEI as the recalling firmOct 20, 200810 years or older, so it adds no points0
Class II recall B-2415-12, this FEI as the recalling firmMar 25, 200810 years or older, so it adds no points0
Class II recall B-0556-13, this FEI as the recalling firmFeb 25, 200810 years or older, so it adds no points0
Class II recall B-2056-12, this FEI as the recalling firmJan 29, 200810 years or older, so it adds no points0
Class II recall B-0306-13, this FEI as the recalling firmJan 21, 200810 years or older, so it adds no points0
Class II recall B-2060-12, this FEI as the recalling firmDec 7, 200710 years or older, so it adds no points0
Class II recall B-1976-12, this FEI as the recalling firmNov 16, 200710 years or older, so it adds no points0
Class II recall B-2059-12, this FEI as the recalling firmOct 25, 200710 years or older, so it adds no points0
Class II recall B-2067-12, this FEI as the recalling firmSep 7, 200710 years or older, so it adds no points0
Class II recall B-1983-12, this FEI as the recalling firmApr 21, 200710 years or older, so it adds no points0
Class II recall B-0268-13, this FEI as the recalling firmApr 20, 200710 years or older, so it adds no points0
Class II recall B-2022-12, this FEI as the recalling firmApr 20, 200710 years or older, so it adds no points0
Class II recall B-1981-12, this FEI as the recalling firmApr 11, 200710 years or older, so it adds no points0
Class II recall B-2040-12, this FEI as the recalling firmFeb 17, 200710 years or older, so it adds no points0
Class II recall B-1979-12, this FEI as the recalling firmNov 1, 200610 years or older, so it adds no points0
Class II recall B-0271-13, this FEI as the recalling firmSep 21, 200610 years or older, so it adds no points0
Class II recall B-2024-12, this FEI as the recalling firmAug 23, 200610 years or older, so it adds no points0
Class II recall B-0272-13, this FEI as the recalling firmAug 8, 200610 years or older, so it adds no points0
Class II recall B-2030-12, this FEI as the recalling firmAug 2, 200610 years or older, so it adds no points0
Class II recall B-0273-13, this FEI as the recalling firmMay 17, 200510 years or older, so it adds no points0
Class II recall B-2359-12, this FEI as the recalling firmFeb 28, 200510 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 15, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 15, 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 15, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 15, 2026Newest record Nov 5, 2026Current

Reviewing Innovative Blood Resources, A Division Of New York Blood Center, Inc. as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Innovative Blood Resources, A Division Of New York Blood Center, Inc. yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Facility details

Company
Innovative Blood Resources, A Division Of New York Blood Center, Inc.
Location
Lincoln, NE (US)
Source
inspections

FDA data resources

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