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Versiti Michigan Inc FDA Inspection Record

FEI 1876522 · Inspections, Form 483s, warning letters and import refusals

Versiti Michigan Inc is an FDA-inspected facility (FEI 1876522) located in Saginaw, MI, US. RegDataLab tracks 6 FDA inspections at this facility.

What FDA found at this site

Latest inspection: Sep 26, 2024: Voluntary Action Indicated (VAI)
Inspections on record: 6 (2 VAI, 4 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: 45, latest Nov 10, 2023

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.

Date	Result	What FDA cited
Sep 26, 2024	Voluntary Action Indicated (VAI)	Concurrent documentation (21 CFR 606.160(a)(1))
Oct 30, 2019	Voluntary Action Indicated (VAI)	Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b))
Jul 13, 2018	No Action Indicated (NAI)	No citations listed
Apr 13, 2016	No Action Indicated (NAI)	No citations listed
Mar 11, 2014	No Action Indicated (NAI)	No citations listed
Mar 29, 2012	No Action Indicated (NAI)	No citations listed

Recalls

Showing the 10 most recent of 45 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
Nov 10, 2023	Class III	B-0065-2024	Red Blood Cells, Leukocytes Reduced Red Blood Cell products, lacking assurance of proper temperature monitoring, were distributed.
Feb 16, 2023	Class III	B-0394-2023	Red Blood Cells, Leukocytes Reduced Red Blood Cell product, for which a visual inspection was not performed or documented, was distributed.
Oct 11, 2022	Class II	B-0253-2023	Red Blood Cells, Leukocytes Reduced, Irradiated Irradiated Red Blood Cell products, not prepared according to specifications, were distributed.
May 19, 2022	Class III	B-0004-2023	Apheresis Platelets, Leukocytes Reduced, Irradiated Leukoreduced Apheresis Platelets, Irradiated, with no record of proper temperature during shipping, were distributed.
Nov 26, 2021	Class III	B-0210-2022	Red Blood Cells, Leukocytes Reduced, Irradiated and 1 more product Blood products, for which storage temperature was not documented, were distributed.
Nov 20, 2020	Class III	B-0220-2021	Red Blood Cells, Leukocytes Reduced Leukoreduced, Red Blood Cells were distributed without a final visual check.
Apr 9, 2020	Class II	B-0519-2020	Blood and Blood Products for Reprocessing Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Sep 24, 2019	Class III	B-0141-2020	Red Blood Cells, Leukocytes Reduced, Irradiated Irradiated Red Blood Cells, Leukoreduced, which were missing an expiration date on the label, were distributed.
May 11, 2018	Class II	B-0679-2018	Pooled Cryoprecipitated AHF and 1 more product Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Sep 19, 2017	Class II	B-0285-2018	Pooled Cryoprecipitated AHF and 2 more products Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

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 14, 2026	Newest record Nov 5, 2026	Current
Inspection citations	Nov 14, 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 14, 2026	Newest record Nov 11, 2026	Current
Form 483s and inspection documents	Nov 13, 2026	Newest record Nov 12, 2026	Current
Import refusals	Nov 2, 2026	Newest record Oct 22, 2026	Current

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Facility details

Company: Versiti Michigan Inc
Location: Saginaw, MI (US)
Source: inspections