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Versiti Michigan, Inc FDA Inspection Record

FEI 1000517886 · Inspections, Form 483s, warning letters and import refusals

Versiti Michigan, Inc is an FDA-inspected facility (FEI 1000517886) located in Traverse City, MI, US. RegDataLab tracks 7 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Apr 11, 2025: Voluntary Action Indicated (VAI)
Inspections on record
7 (2 VAI, 5 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
29, latest Jun 1, 2022

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 11, 2025Voluntary Action Indicated (VAI)Retention period (21 CFR 606.160(d))
Jun 27, 2019No Action Indicated (NAI)No citations listed
Apr 5, 2017No Action Indicated (NAI)No citations listed
Jun 17, 2015No Action Indicated (NAI)No citations listed
Nov 9, 2012Voluntary Action Indicated (VAI)Donor suitability procedures not followed (21 CFR 640.3(a)(1))
Nov 18, 2010No Action Indicated (NAI)No citations listed
Jan 15, 2009No Action Indicated (NAI)No citations listed

Recalls

Showing the 10 most recent of 29 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
Jun 1, 2022Class IIB-0152-2023Red Blood Cells, Leukocytes Reduced, Irradiated and 2 more products
Blood products, collected in a manner with a potential for air contamination, were distributed.
Oct 26, 2018Class IIIB-0213-2019PF24 Plasma
Blood product, collected from an ineligible donor, was distributed.
Feb 9, 2018Class IIIB-0549-2018Apheresis Red Blood Cells, Leukocytes Reduced and 1 more product
Red Blood Cells, not meeting product specifications, were distributed.
Nov 29, 2017Class IIIB-0299-2018PF24 Plasma
Blood products, which were not prepared within the appropriate time frame after collection, were distributed.
Sep 30, 2016Class IIB-0186-2017Blood and Blood Products for Reprocessing and 1 more product
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Jun 24, 2008Class IIIB-1927-08Recovered Plasma and 1 more product
Blood product, collected from a donor who received a bone graft within one year of donation, was distributed.
Feb 29, 2008Class IIB-1700-08Red blood cells. and 2 more products
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed
Feb 25, 2008Class IIIB-1633-08Platelets.
Blood products, for which the quality control testing was incomplete, were distributed.
Feb 22, 2008Class IIIB-1593-08Recovered Plasma and 2 more products
Blood product, collected from a donor for whom there was no documentation on the donor record of an arm inspection, was distributed.
Nov 26, 2007Class IIB-1113-08Platelets
Blood product, which did not meet acceptable product specifications, 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
Traverse City, MI (US)
Source
inspections

FDA data resources

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