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Vitalant FDA Inspection Record

FEI 1771452 · Inspections, Form 483s, warning letters and import refusals

Vitalant is an FDA-inspected facility (FEI 1771452) located in Fargo, ND, US. RegDataLab tracks 6 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
Apr 29, 2025: No Action Indicated (NAI)
Inspections on record
6 (6 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
34, latest Nov 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
Apr 29, 2025No Action Indicated (NAI)No citations listed
Jun 7, 2019No Action Indicated (NAI)No citations listed
Dec 20, 2016No Action Indicated (NAI)No citations listed
May 7, 2015No Action Indicated (NAI)No citations listed
Apr 22, 2013No Action Indicated (NAI)No citations listed
Mar 29, 2012No Action Indicated (NAI)No citations listed

Recalls

Showing the 10 most recent of 34 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
Nov 27, 2024Class IIB-0125-2025Apheresis Platelets, Leukocytes Reduced, Irradiated
Leukoreduced Platelets Products, which were not tested for pH, were distributed.
Apr 11, 2024Class IIB-0385-2024Red Blood Cells, Leukocytes Reduced
Red Blood Cells products, for which quality control for antigen screening was not performed, were distributed.
Dec 6, 2022Class IIB-0237-2023Whole Blood, Leukocytes Reduced
Leukoreduced Whole Blood, which were labeled as leukocytes reduced but were not tested to verify white blood cell count, were distributed.
Dec 30, 2021Class IIB-0237-2022Apheresis Platelets, Leukocytes Reduced, Irradiated and 1 more product
Blood products, which were labeled as leukocytes reduced but failed the monthly QC residual white blood cell count, were distributed.
Jul 30, 2021Class IIIB-0597-2021Blood and Blood Products for Reprocessing
Blood product, for which donor eligibility was incomplete, was distributed.
Jun 9, 2021Class IIIB-0578-2021Apheresis Red Blood Cells, Leukocytes Reduced
Apheresis Red Blood Cell product, not meeting product specifications, was distributed.
Nov 25, 2020Class IIIB-0178-2021Apheresis Platelets, Leukocytes Reduced, Irradiated
Plateletpheresis products, for which was reissued without a record of proper temperature maintenance, were distributed.
Jan 3, 2020Class IIIB-0314-2020Red Blood Cells, Leukocytes Reduced
Red Blood Cell product for which a visual inspection was not performed or documented, was distributed.
Nov 8, 2019Class IIIB-0244-2020Apheresis Red Blood Cells, Leukocytes Reduced
Apheresis Red Blood Cell product for which a visual inspection was not performed or documented, was distributed.
Aug 9, 2019Class IIIB-0047-2020Red Blood Cells, Leukocytes Reduced
Leukoreduced Red Blood Cells were distributed without a final visual check.

Facility details

Company
Vitalant
Location
Fargo, ND (US)
Source
inspections

FDA data resources

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