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Versiti Michigan Inc FDA Inspection Record

FEI 3011640049 · Inspections, Form 483s, warning letters and import refusals

Versiti Michigan Inc is an FDA-inspected facility (FEI 3011640049) located in Livonia, MI, US. RegDataLab tracks 2 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Apr 21, 2021: No Action Indicated (NAI)
Inspections on record
2 (2 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
5, latest Apr 16, 2021

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 21, 2021No Action Indicated (NAI)No citations listed
Jul 26, 2018No Action Indicated (NAI)No citations listed

Recalls

Newest first. 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
Apr 16, 2021Class IIIB-0528-2021Red Blood Cells, Leukocytes Reduced
Red Blood Cell products, for which a visual inspection was not performed or documented, were distributed.
Mar 10, 2021Class IIB-0456-2021Apheresis Red Blood Cells, Leukocytes Reduced
Apheresis Red Blood Cell products, labeled with incorrect or missing information, were distributed.
Dec 19, 2020Class IIIB-0310-2021Red Blood Cells, Leukocytes Reduced, Irradiated
Misbranded Red Blood Cell product was distributed.
May 14, 2019Class IIIB-0221-2020Red Blood Cells Deglycerolized, Leukocytes Reduced
Red Blood Cells were issued without a documented visual inspection.
Mar 28, 2016Class IIB-0572-16Red Blood Cells, Leukocytes Reduced
Blood product, altered in a manner that possibly compromised sterility, was distributed.

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
Versiti Michigan Inc
Location
Livonia, MI (US)
Source
inspections

FDA data resources

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