Home / Facilities / 1076019

Vitalant FDA Inspection Record

FEI 1076019 · Inspections, Form 483s, warning letters and import refusals

Vitalant is an FDA-inspected facility (FEI 1076019) located in Memphis, TN, US. RegDataLab tracks 11 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Mar 26, 2025: No Action Indicated (NAI)
Inspections on record
11 (3 VAI, 8 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
31, latest Feb 26, 2020

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

Showing the 10 most recent of 11 inspections. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
Mar 26, 2025No Action Indicated (NAI)No citations listed
May 11, 2023No Action Indicated (NAI)No citations listed
May 9, 2019Voluntary Action Indicated (VAI)Equipment calibration frequency (21 CFR 606.60(b))
Jul 20, 2017No Action Indicated (NAI)No citations listed
Aug 13, 2015No Action Indicated (NAI)No citations listed
Jul 11, 2014No Action Indicated (NAI)No citations listed
Apr 27, 2012Voluntary Action Indicated (VAI)No citations listed
Aug 13, 2010Voluntary Action Indicated (VAI)No citations listed
Aug 2, 2010No Action Indicated (NAI)No citations listed
Jul 9, 2010No Action Indicated (NAI)No citations listed

Recalls

Showing the 10 most recent of 31 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
Feb 26, 2020Class IIB-0460-2020Apheresis Red Blood Cells, Leukocytes Reduced and 1 more product
Red Blood cells, possibly misbranded for a membrane antigen, were distributed.
Dec 4, 2019Class IIIB-0265-2020Red Blood Cells, Leukocytes Reduced
Blood product, that lacked assurance of proper distribution and storage requirements, was distributed.
Sep 11, 2019Class IIIB-0103-2020PF24 Plasma
Blood product for which a visual inspection was not performed or documented was distributed
Jan 21, 2019Class IIIB-0525-2019PF24 Plasma and 2 more products
Blood products, where donor testing was incorrectly performed for evidence of infection due to a relevant transfusion-transmitted infection…
Oct 2, 2018Class IIB-0066-2019Red Blood Cells, Leukocytes Reduced, Irradiated and 1 more product
Blood products, not meeting product specifications, were distributed.
May 4, 2018Class IIIB-0637-2018Red Blood Cells, Leukocytes Reduced
Blood product, labeled with a combination of incorrect or missing information was distributed.
May 3, 2018Class IIB-0642-2018Red Blood Cells, Leukocytes Reduced
Blood products, collected from a donor whose eligibility to donate was inadequately determined for malarial travel, were distributed.
Mar 9, 2018Class IIIB-0520-2018Apheresis Red Blood Cells, Leukocytes Reduced
Apheresis product, which was irradiated labeled with an incorrect expiration date, was distributed.
Nov 9, 2017Class IIB-0244-2018Blood and Blood Products for Reprocessing and 1 more product
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Nov 6, 2017Class IIB-0238-2018Red Blood Cells, Leukocytes Reduced and 1 more product
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.

FDA record score

10 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.

27 records behind this number
RecordDatePoints x age weightAdds
Inspection classified VAIMay 9, 20196 x 0.251.5
Class II recall B-0460-2020, this FEI as the recalling firmFeb 26, 20204 x 0.251
Class II recall B-0066-2019, this FEI as the recalling firmOct 2, 20184 x 0.251
Class II recall B-0642-2018, this FEI as the recalling firmMay 3, 20184 x 0.251
Class II recall B-0244-2018, this FEI as the recalling firmNov 9, 20174 x 0.251
Class II recall B-0238-2018, this FEI as the recalling firmNov 6, 20174 x 0.251
Class II recall B-0887-2017, this FEI as the recalling firmJul 31, 20174 x 0.251
Class II recall B-0527-2017, this FEI as the recalling firmMar 1, 20174 x 0.251
Class II recall B-0482-2017, this FEI as the recalling firmFeb 24, 20174 x 0.251
Class II recall B-0108-16, this FEI as the recalling firmSep 11, 201510 years or older, so it adds no points0
Class II recall B-0550-14, this FEI as the recalling firmJan 27, 201410 years or older, so it adds no points0
Class II recall B-0416-14, this FEI as the recalling firmJan 6, 201410 years or older, so it adds no points0
Class II recall B-0256-14, this FEI as the recalling firmSep 26, 201310 years or older, so it adds no points0
Class II recall B-0092-14, this FEI as the recalling firmSep 12, 201310 years or older, so it adds no points0
Class II recall B-2532-13, this FEI as the recalling firmJul 22, 201310 years or older, so it adds no points0
Class II recall B-0949-13, this FEI as the recalling firmDec 27, 201210 years or older, so it adds no points0
Class II recall B-1008-13, this FEI as the recalling firmDec 10, 201210 years or older, so it adds no points0
Inspection classified VAIApr 27, 201210 years or older, so it adds no points0
Inspection classified VAIAug 13, 201010 years or older, so it adds no points0
Class II recall B-1966-08, this FEI as the recalling firmJun 9, 200810 years or older, so it adds no points0
Class II recall B-1965-08, this FEI as the recalling firmApr 30, 200810 years or older, so it adds no points0
Class II recall B-1963-08, this FEI as the recalling firmSep 4, 200710 years or older, so it adds no points0
Class II recall B-1574-6, this FEI as the recalling firmOct 12, 200410 years or older, so it adds no points0
Class II recall B-0107-7, this FEI as the recalling firmAug 27, 200410 years or older, so it adds no points0
Class II recall B-0106-7, this FEI as the recalling firmJun 28, 200410 years or older, so it adds no points0
Class II recall B-1750-4, this FEI as the recalling firmMar 4, 200410 years or older, so it adds no points0
Class II recall B-1716-4, this FEI as the recalling firmSep 5, 200110 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
Vitalant
Location
Memphis, TN (US)
Source
inspections

FDA data resources

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