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Versiti Michigan Inc FDA Inspection Record

FEI 3005861846 · Inspections, Form 483s, warning letters and import refusals

Versiti Michigan Inc is an FDA-inspected facility (FEI 3005861846) located in Saint Joseph, MI, US. RegDataLab tracks 6 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Oct 2, 2019: 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
3, latest Jun 6, 2008

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
Oct 2, 2019No Action Indicated (NAI)No citations listed
Oct 25, 2017No Action Indicated (NAI)No citations listed
Dec 16, 2015No Action Indicated (NAI)No citations listed
Dec 17, 2013No Action Indicated (NAI)No citations listed
Dec 13, 2011No Action Indicated (NAI)No citations listed
Nov 25, 2009No 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
Jun 6, 2008Class IIB-1980-08Red Blood Cells Leukocytes Reduced.
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed
May 19, 2008Class IIB-1684-08Recovered Plasma and 1 more product
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Oct 20, 2007Class IIB-1099-08Platelets Irradiated
Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, 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
Saint Joseph, MI (US)
Source
inspections

FDA data resources

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