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Versiti Wisconsin, Inc FDA Inspection Record

FEI 2171378 · Inspections, Form 483s, warning letters and import refusals

Versiti Wisconsin, Inc is an FDA-inspected facility (FEI 2171378) located in Milwaukee, WI, US. RegDataLab tracks 15 FDA inspections at this facility.

What FDA found at this site

Latest inspection: Jul 17, 2026: No Action Indicated (NAI)
Inspections on record: 15 (4 VAI, 11 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: 187, latest Mar 19, 2025

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 15 inspections. Citations are the inspector observations FDA publishes for the inspection.

Date	Result	What FDA cited
Jul 17, 2026	No Action Indicated (NAI)	No citations listed
Mar 4, 2024	No Action Indicated (NAI)	No citations listed
Apr 26, 2023	No Action Indicated (NAI)	No citations listed
Dec 13, 2019	No Action Indicated (NAI)	No citations listed
Aug 23, 2018	No Action Indicated (NAI)	No citations listed
Dec 11, 2017	No Action Indicated (NAI)	No citations listed
Jun 16, 2016	Voluntary Action Indicated (VAI)	Additional Medical Assessment Factors (21 CFR 630.10(e)(2)) One or more approved screening tests (21 CFR 610.40(b))
Sep 23, 2015	No Action Indicated (NAI)	No citations listed
Sep 19, 2014	No Action Indicated (NAI)	No citations listed
Oct 2, 2012	No Action Indicated (NAI)	No citations listed

Recalls

Showing the 10 most recent of 187 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
Mar 19, 2025	Class III	B-0005-2026	Red Blood Cells, Leukocytes Reduced, Irradiated Red Blood Cells, Leukocytes Reduced, Irradiated, for which a visual inspection was not performed or documented, were distributed.
Nov 6, 2024	Class II	B-0175-2025	Apheresis Platelets, Leukocytes Reduced, Irradiated Leukoreduced Apheresis Platelets, Irradiated, for which documentation of irradiation was incomplete, were distributed.
Oct 30, 2024	Class III	B-0246-2025	Apheresis Red Blood Cells, Leukocytes Reduced Leukoreduced, Apheresis Red Blood Cell products, which lacked documentation of acceptable storage temperature, were distributed.
Oct 2, 2024	Class II	B-0088-2025	Apheresis Platelets, Leukocytes Reduced, Irradiated Leukoreduced Apheresis Platelets, Irradiated, which were returned at an unacceptible temperature, were distributed.
Sep 27, 2024	Class III	B-0245-2025	Apheresis Platelets, Leukocytes Reduced, Irradiated Leukoreduced, Apheresis Platelets, Irradiated, shipped without documentation of acceptable temperature, were distributed.
Apr 10, 2024	Class II	B-0373-2024	Apheresis Platelets, Leukocytes Reduced Leukoreduced Platelets products, which were labeled as leukocytes reduced but were not tested to verify white blood cell count, were…
Feb 27, 2024	Class III	B-0279-2024	Apheresis Platelets, Leukocytes Reduced Leukoreduced Apheresis Platelets, returned without documenting the shipping temperature, was distributed.
Dec 5, 2023	Class III	B-0228-2024	Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated Apheresis Red Blood Cell product, lacking assurance of proper storage temperature, was distributed.
Nov 22, 2023	Class II	B-0139-2024	PF24 Plasma Blood product identified as unsuitable due to a reactive screening test for transfusion-transmitted infection, was distributed.
Sep 19, 2023	Class II	B-0064-2024	Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced Leukoreduced Apheresis Platelets, Pathogen Reduced, with a platelet count higher than was acceptable, was distributed.

FDA record score

65 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.

151 records behind this number

Record	Date	Points x age weight	Adds
Class II recall B-0175-2025, this FEI as the recalling firm	Nov 6, 2024	4 x 0.6	2.4
Class II recall B-0088-2025, this FEI as the recalling firm	Oct 2, 2024	4 x 0.6	2.4
Class II recall B-0373-2024, this FEI as the recalling firm	Apr 10, 2024	4 x 0.6	2.4
Class II recall B-0139-2024, this FEI as the recalling firm	Nov 22, 2023	4 x 0.6	2.4
Class II recall B-0064-2024, this FEI as the recalling firm	Sep 19, 2023	4 x 0.6	2.4
Class II recall B-0050-2024, this FEI as the recalling firm	Sep 13, 2023	4 x 0.6	2.4
Class II recall B-0527-2023, this FEI as the recalling firm	May 4, 2023	4 x 0.6	2.4
Class II recall B-0446-2023, this FEI as the recalling firm	Aug 23, 2022	4 x 0.6	2.4
Class II recall B-0447-2023, this FEI as the recalling firm	Aug 23, 2022	4 x 0.6	2.4
Class II recall B-0163-2023, this FEI as the recalling firm	Jul 17, 2022	4 x 0.6	2.4
Class II recall B-0165-2023, this FEI as the recalling firm	May 31, 2022	4 x 0.6	2.4
Class II recall B-0435-2022, this FEI as the recalling firm	May 3, 2022	4 x 0.6	2.4
Class II recall B-0346-2022, this FEI as the recalling firm	Mar 9, 2022	4 x 0.6	2.4
Class II recall B-0413-2022, this FEI as the recalling firm	Feb 17, 2022	4 x 0.6	2.4
Class II recall B-0057-2022, this FEI as the recalling firm	Sep 17, 2021	4 x 0.25	1
Class II recall B-0048-2022, this FEI as the recalling firm	Sep 13, 2021	4 x 0.25	1
Class II recall B-0283-2021, this FEI as the recalling firm	Dec 17, 2020	4 x 0.25	1
Class II recall B-0134-2020, this FEI as the recalling firm	Sep 19, 2019	4 x 0.25	1
Class II recall B-0470-2019, this FEI as the recalling firm	Feb 15, 2019	4 x 0.25	1
Class II recall B-0286-2019, this FEI as the recalling firm	Dec 31, 2018	4 x 0.25	1
Class II recall B-0264-2019, this FEI as the recalling firm	Nov 8, 2018	4 x 0.25	1
Class II recall B-0031-2019, this FEI as the recalling firm	Aug 22, 2018	4 x 0.25	1
Class II recall B-0808-2018, this FEI as the recalling firm	Jul 20, 2018	4 x 0.25	1
Class II recall B-0671-2018, this FEI as the recalling firm	Apr 25, 2018	4 x 0.25	1
Class II recall B-0540-2018, this FEI as the recalling firm	Feb 26, 2018	4 x 0.25	1
Class II recall B-0410-2018, this FEI as the recalling firm	Jan 22, 2018	4 x 0.25	1
Class II recall B-0377-2018, this FEI as the recalling firm	Jan 16, 2018	4 x 0.25	1
Class II recall B-0398-2018, this FEI as the recalling firm	Dec 22, 2017	4 x 0.25	1
Class II recall B-0341-2018, this FEI as the recalling firm	Nov 20, 2017	4 x 0.25	1
Class II recall B-0263-2018, this FEI as the recalling firm	Nov 13, 2017	4 x 0.25	1
Class II recall B-0246-2018, this FEI as the recalling firm	Oct 30, 2017	4 x 0.25	1
Class II recall B-0785-2017, this FEI as the recalling firm	Jun 20, 2017	4 x 0.25	1
Class II recall B-0725-2017, this FEI as the recalling firm	May 15, 2017	4 x 0.25	1
Class II recall B-0726-2017, this FEI as the recalling firm	May 15, 2017	4 x 0.25	1
Class II recall B-0747-2017, this FEI as the recalling firm	May 9, 2017	4 x 0.25	1
Class II recall B-0709-2017, this FEI as the recalling firm	Apr 26, 2017	4 x 0.25	1
Class II recall B-0581-2017, this FEI as the recalling firm	Apr 11, 2017	4 x 0.25	1
Class II recall B-0605-2017, this FEI as the recalling firm	Apr 11, 2017	4 x 0.25	1
Class II recall B-0618-2017, this FEI as the recalling firm	Mar 20, 2017	4 x 0.25	1
Class II recall B-0619-2017, this FEI as the recalling firm	Mar 7, 2017	4 x 0.25	1
Class II recall B-0509-2017, this FEI as the recalling firm	Feb 20, 2017	4 x 0.25	1
Class II recall B-0378-2017, this FEI as the recalling firm	Dec 29, 2016	4 x 0.25	1
Class II recall B-0505-2017, this FEI as the recalling firm	Dec 22, 2016	4 x 0.25	1
Class II recall B-0287-2017, this FEI as the recalling firm	Nov 22, 2016	4 x 0.25	1
Class II recall B-0291-2017, this FEI as the recalling firm	Nov 22, 2016	4 x 0.25	1
Class II recall B-0200-2017, this FEI as the recalling firm	Oct 13, 2016	10 years or older, so it adds no points	0
Class II recall B-0179-2017, this FEI as the recalling firm	Oct 11, 2016	10 years or older, so it adds no points	0
Class II recall B-0250-2017, this FEI as the recalling firm	Oct 11, 2016	10 years or older, so it adds no points	0
Class II recall B-0143-2017, this FEI as the recalling firm	Sep 20, 2016	10 years or older, so it adds no points	0
Class II recall B-0176-2017, this FEI as the recalling firm	Sep 20, 2016	10 years or older, so it adds no points	0
Class II recall B-0095-2017, this FEI as the recalling firm	Sep 9, 2016	10 years or older, so it adds no points	0
Class II recall B-0031-2017, this FEI as the recalling firm	Aug 10, 2016	10 years or older, so it adds no points	0
Class II recall B-0033-2017, this FEI as the recalling firm	Aug 10, 2016	10 years or older, so it adds no points	0
Class II recall B-0698-16, this FEI as the recalling firm	Jun 17, 2016	10 years or older, so it adds no points	0
Class II recall B-0681-16, this FEI as the recalling firm	Jun 16, 2016	10 years or older, so it adds no points	0
Inspection classified VAI	Jun 16, 2016	10 years or older, so it adds no points	0
Class II recall B-0598-16, this FEI as the recalling firm	May 17, 2016	10 years or older, so it adds no points	0
Class II recall B-0387-16, this FEI as the recalling firm	Feb 1, 2016	10 years or older, so it adds no points	0
Class II recall B-0389-16, this FEI as the recalling firm	Feb 1, 2016	10 years or older, so it adds no points	0
Class II recall B-0393-16, this FEI as the recalling firm	Feb 1, 2016	10 years or older, so it adds no points	0
Class II recall B-0391-16, this FEI as the recalling firm	Jan 27, 2016	10 years or older, so it adds no points	0
Class II recall B-0227-16, this FEI as the recalling firm	Dec 16, 2015	10 years or older, so it adds no points	0
Class II recall B-0143-16, this FEI as the recalling firm	Oct 2, 2015	10 years or older, so it adds no points	0
Class II recall B-0105-16, this FEI as the recalling firm	Sep 22, 2015	10 years or older, so it adds no points	0
Class II recall B-0037-16, this FEI as the recalling firm	Jul 21, 2015	10 years or older, so it adds no points	0
Class II recall B-0873-15, this FEI as the recalling firm	Jun 3, 2015	10 years or older, so it adds no points	0
Class II recall B-0617-15, this FEI as the recalling firm	Feb 25, 2015	10 years or older, so it adds no points	0
Class II recall B-0443-15, this FEI as the recalling firm	Feb 24, 2015	10 years or older, so it adds no points	0
Class II recall B-0338-15, this FEI as the recalling firm	Nov 25, 2014	10 years or older, so it adds no points	0
Class II recall B-0677-15, this FEI as the recalling firm	Aug 12, 2014	10 years or older, so it adds no points	0
Class II recall B-0883-14, this FEI as the recalling firm	May 13, 2014	10 years or older, so it adds no points	0
Class II recall B-0637-14, this FEI as the recalling firm	Feb 18, 2014	10 years or older, so it adds no points	0
Class II recall B-0506-14, this FEI as the recalling firm	Jan 23, 2014	10 years or older, so it adds no points	0
Class II recall B-1444-13, this FEI as the recalling firm	Feb 1, 2013	10 years or older, so it adds no points	0
Class II recall B-1184-13, this FEI as the recalling firm	Jan 17, 2013	10 years or older, so it adds no points	0
Class II recall B-1084-13, this FEI as the recalling firm	Dec 4, 2012	10 years or older, so it adds no points	0
Class II recall B-0869-13, this FEI as the recalling firm	Nov 20, 2012	10 years or older, so it adds no points	0
Class II recall B-0158-13, this FEI as the recalling firm	Aug 14, 2012	10 years or older, so it adds no points	0
Inspection classified VAI	Aug 10, 2012	10 years or older, so it adds no points	0
Class II recall B-2332-12, this FEI as the recalling firm	May 16, 2012	10 years or older, so it adds no points	0
Inspection classified VAI	Jul 13, 2011	10 years or older, so it adds no points	0
Inspection classified VAI	Aug 18, 2010	10 years or older, so it adds no points	0
Class II recall B-0936-07, this FEI as the recalling firm	Jun 23, 2006	10 years or older, so it adds no points	0
Class II recall B-0215-07, this FEI as the recalling firm	Jun 16, 2006	10 years or older, so it adds no points	0
Class II recall B-0462-08, this FEI as the recalling firm	Dec 12, 2005	10 years or older, so it adds no points	0
Class II recall B-0193-08, this FEI as the recalling firm	Aug 31, 2005	10 years or older, so it adds no points	0
Class II recall B-0172-08, this FEI as the recalling firm	Aug 8, 2005	10 years or older, so it adds no points	0
Class II recall B-0188-08, this FEI as the recalling firm	Aug 2, 2005	10 years or older, so it adds no points	0
Class II recall B-0464-08, this FEI as the recalling firm	Jul 19, 2005	10 years or older, so it adds no points	0
Class II recall B-0401-08, this FEI as the recalling firm	Jul 18, 2005	10 years or older, so it adds no points	0
Class II recall B-0346-08, this FEI as the recalling firm	Jul 12, 2005	10 years or older, so it adds no points	0
Class II recall B-0459-08, this FEI as the recalling firm	Jun 22, 2005	10 years or older, so it adds no points	0
Class II recall B-0447-08, this FEI as the recalling firm	Jun 17, 2005	10 years or older, so it adds no points	0
Class II recall B-0455-08, this FEI as the recalling firm	Jun 16, 2005	10 years or older, so it adds no points	0
Class II recall B-0402-08, this FEI as the recalling firm	Jun 13, 2005	10 years or older, so it adds no points	0
Class II recall B-0347-08, this FEI as the recalling firm	Apr 22, 2005	10 years or older, so it adds no points	0
Class II recall B-0234-08, this FEI as the recalling firm	Mar 25, 2005	10 years or older, so it adds no points	0
Class II recall B-0403-08, this FEI as the recalling firm	Mar 5, 2005	10 years or older, so it adds no points	0
Class II recall B-0394-08, this FEI as the recalling firm	Mar 3, 2005	10 years or older, so it adds no points	0
Class II recall B-0396-08, this FEI as the recalling firm	Feb 24, 2005	10 years or older, so it adds no points	0
Class II recall B-0426-08, this FEI as the recalling firm	Jan 24, 2005	10 years or older, so it adds no points	0
Class II recall B-0192-08, this FEI as the recalling firm	Dec 28, 2004	10 years or older, so it adds no points	0
Class II recall B-0009-7, this FEI as the recalling firm	Jul 29, 2004	10 years or older, so it adds no points	0
Class II recall B-0010-7, this FEI as the recalling firm	Jul 6, 2004	10 years or older, so it adds no points	0
Class II recall B-0419-7, this FEI as the recalling firm	Jun 25, 2004	10 years or older, so it adds no points	0
Class II recall B-1040-6, this FEI as the recalling firm	Jun 13, 2004	10 years or older, so it adds no points	0
Class II recall B-1278-6, this FEI as the recalling firm	Jun 12, 2004	10 years or older, so it adds no points	0
Class II recall B-1281-6, this FEI as the recalling firm	Jun 2, 2004	10 years or older, so it adds no points	0
Class II recall B-1171-6, this FEI as the recalling firm	May 25, 2004	10 years or older, so it adds no points	0
Class II recall B-1350-6, this FEI as the recalling firm	May 25, 2004	10 years or older, so it adds no points	0
Class II recall B-1492-07, this FEI as the recalling firm	Feb 23, 2004	10 years or older, so it adds no points	0
Class II recall B-1509-07, this FEI as the recalling firm	Feb 17, 2004	10 years or older, so it adds no points	0
Class II recall B-1474-07, this FEI as the recalling firm	Feb 14, 2004	10 years or older, so it adds no points	0
Class II recall B-1422-07, this FEI as the recalling firm	Jan 29, 2004	10 years or older, so it adds no points	0
Class II recall B-1498-07, this FEI as the recalling firm	Jan 13, 2004	10 years or older, so it adds no points	0
Class II recall B-1496-07, this FEI as the recalling firm	Jan 5, 2004	10 years or older, so it adds no points	0
Class II recall B-0913-07, this FEI as the recalling firm	Nov 6, 2003	10 years or older, so it adds no points	0
Class II recall B-0050-08, this FEI as the recalling firm	Oct 3, 2003	10 years or older, so it adds no points	0
Class II recall B-0961-07, this FEI as the recalling firm	Sep 23, 2003	10 years or older, so it adds no points	0
Class II recall B-0907-07, this FEI as the recalling firm	Sep 11, 2003	10 years or older, so it adds no points	0
Class II recall B-0910-07, this FEI as the recalling firm	Jul 23, 2003	10 years or older, so it adds no points	0
Class II recall B-1317-07, this FEI as the recalling firm	Jul 16, 2003	10 years or older, so it adds no points	0
Class II recall B-0914-07, this FEI as the recalling firm	Jul 14, 2003	10 years or older, so it adds no points	0
Class II recall B-0909-07, this FEI as the recalling firm	Jul 9, 2003	10 years or older, so it adds no points	0
Class II recall B-0911-07, this FEI as the recalling firm	Jun 30, 2003	10 years or older, so it adds no points	0
Class II recall B-0985-07, this FEI as the recalling firm	Jun 27, 2003	10 years or older, so it adds no points	0
Class II recall B-1347-07, this FEI as the recalling firm	Jun 25, 2003	10 years or older, so it adds no points	0
Class II recall B-1349-07, this FEI as the recalling firm	Jun 23, 2003	10 years or older, so it adds no points	0
Class II recall B-1373-07, this FEI as the recalling firm	Jun 18, 2003	10 years or older, so it adds no points	0
Class II recall B-0983-07, this FEI as the recalling firm	Jun 16, 2003	10 years or older, so it adds no points	0
Class II recall B-1651-4, this FEI as the recalling firm	Jun 11, 2003	10 years or older, so it adds no points	0
Class II recall B-0035-7, this FEI as the recalling firm	Jun 6, 2003	10 years or older, so it adds no points	0
Class II recall B-0037-7, this FEI as the recalling firm	Jun 6, 2003	10 years or older, so it adds no points	0
Class II recall B-0930-07, this FEI as the recalling firm	Jun 6, 2003	10 years or older, so it adds no points	0
Class II recall B-1073-07, this FEI as the recalling firm	Jun 6, 2003	10 years or older, so it adds no points	0
Class II recall B-0039-7, this FEI as the recalling firm	Jun 4, 2003	10 years or older, so it adds no points	0
Class II recall B-0086-7, this FEI as the recalling firm	May 26, 2003	10 years or older, so it adds no points	0
Class II recall B-0084-7, this FEI as the recalling firm	May 16, 2003	10 years or older, so it adds no points	0
Class II recall B-0969-07, this FEI as the recalling firm	Apr 9, 2003	10 years or older, so it adds no points	0
Class II recall B-0038-7, this FEI as the recalling firm	Apr 4, 2003	10 years or older, so it adds no points	0
Class II recall B-1648-4, this FEI as the recalling firm	Jan 20, 2003	10 years or older, so it adds no points	0
Class II recall B-1650-4, this FEI as the recalling firm	Jan 17, 2003	10 years or older, so it adds no points	0
Class II recall B-1746-4, this FEI as the recalling firm	Jan 14, 2003	10 years or older, so it adds no points	0
Class II recall B-1542-4, this FEI as the recalling firm	Dec 11, 2002	10 years or older, so it adds no points	0
Class II recall B-1543-4, this FEI as the recalling firm	Nov 29, 2002	10 years or older, so it adds no points	0
Class II recall B-1553-4, this FEI as the recalling firm	Oct 31, 2002	10 years or older, so it adds no points	0
Class II recall B-1545-4, this FEI as the recalling firm	Oct 28, 2002	10 years or older, so it adds no points	0
Class II recall B-1712-4, this FEI as the recalling firm	Oct 25, 2002	10 years or older, so it adds no points	0
Class II recall B-1747-4, this FEI as the recalling firm	Oct 14, 2002	10 years or older, so it adds no points	0
Class II recall B-1742-4, this FEI as the recalling firm	Oct 11, 2002	10 years or older, so it adds no points	0
Class II recall B-0277-5, this FEI as the recalling firm	Feb 5, 2002	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 15, 2026	Newest record Nov 5, 2026	Current
Inspection citations	Nov 15, 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 15, 2026	Newest record Nov 11, 2026	Current
Form 483s and inspection documents	Nov 13, 2026	Newest record Nov 12, 2026	Current
Import refusals	Nov 15, 2026	Newest record Nov 5, 2026	Current

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Facility details

Company: Versiti Wisconsin, Inc
Location: Milwaukee, WI (US)
Source: inspections