Home / Facilities / 1875548

Versiti Michigan Inc FDA Inspection Record

FEI 1875548 · Inspections, Form 483s, warning letters and import refusals

Versiti Michigan Inc is an FDA-inspected facility (FEI 1875548) located in Grand Rapids, MI, US. RegDataLab tracks 8 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Jun 27, 2024: No Action Indicated (NAI)
Inspections on record
8 (1 VAI, 7 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
113, latest Aug 30, 2024

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
Jun 27, 2024No Action Indicated (NAI)No citations listed
Sep 4, 2020No Action Indicated (NAI)No citations listed
Aug 22, 2018No Action Indicated (NAI)No citations listed
Sep 15, 2016No Action Indicated (NAI)No citations listed
Sep 15, 2016Voluntary Action Indicated (VAI)Establish, maintain and follow manufacturing SOPs (21 CFR 606.100(b))
May 9, 2014No Action Indicated (NAI)No citations listed
Dec 16, 2011No Action Indicated (NAI)No citations listed
Feb 8, 2010No Action Indicated (NAI)No citations listed

Recalls

Showing the 10 most recent of 113 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
Aug 30, 2024Class IIB-0073-2025Apheresis Red Blood Cells, Leukocytes Reduced
Red Blood Cells products, which were labeled as leukocytes reduced but were not tested to verify white blood cell count, and that failed…
Mar 1, 2024Class IIIB-0274-2024Red Blood Cells, Leukocytes Reduced
Red Blood Cells product, for which a visual inspection was not performed or documented was distributed.
Dec 29, 2023Class IIB-0032-2027Red Blood Cells, Leukocytes Reduced
Red Blood Cells, Leukocytes Reduced, quarantined due to Whole Blood collection using a scale that did not undergo daily quality control…
Mar 24, 2023Class IIIB-0422-2023Apheresis Red Blood Cells, Leukocytes Reduced
Apheresis Red Blood Cell Product, without temperature documentation, was distributed.
Jan 6, 2023Class IIB-0357-2023Red Blood Cells, Leukocytes Reduced and 2 more products
Blood Products, collected in a manner that compromises the sterility of the collection system, were distributed.
Dec 5, 2022Class IIB-0345-2023Apheresis Platelets, Leukocytes Reduced
Plateletpheresis product, for which quality control for residual WBC count was not performed, was distributed.
Jul 22, 2022Class IIIB-0189-2023Apheresis Red Blood Cells, Leukocytes Reduced, Irradiated
Leukoreduced Apheresis Red Blood Cells, Irradiated, which were stored at a higher temperature than acceptable, were distributed.
Jul 20, 2022Class IIB-0177-2023Apheresis Red Blood Cells, Leukocytes Reduced
Apheresis Red Blood Cell products, for which quality control testing was not performed, were distributed.
Jul 18, 2022Class IIB-0187-2023Apheresis Platelets, PAS, Leukocytes Reduced
Leukoreduced Apheresis Platelets, PAS, collected in a manner that compromised the sterility of the collection system, was distributed.
Jul 7, 2022Class IIIB-0156-2023Apheresis Red Blood Cells, Leukocytes Reduced and 1 more product
Blood Products, exposed to unacceptable shipping temperatures, were 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

Reviewing Versiti Michigan Inc as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Versiti Michigan Inc yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Facility details

Company
Versiti Michigan Inc
Location
Grand Rapids, MI (US)
Source
inspections

FDA data resources

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