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MIM SOFTWARE INC. FDA Inspection Record

FEI 3004363352 · Inspections, Form 483s, warning letters and import refusals

MIM SOFTWARE INC. is an FDA-registered facility (FEI 3004363352) located in Cleveland, OH, US. RegDataLab tracks 2 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Mar 27, 2015: Voluntary Action Indicated (VAI)
Inspections on record
2 (2 VAI)
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
1, latest Feb 19, 2025

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
Mar 27, 2015Voluntary Action Indicated (VAI)Design validation- Lack of or inadequate procedures (21 CFR 820.30(g))
Design changes - Lack of or Inadequate Procedures (21 CFR 820.30(i))
Lack of or inadequate procedures (21 CFR 820.100(a))
Design Validation - Risk analysis not performed/inadequate (21 CFR 820.30(g))
and 1 more
Sep 2, 2011Voluntary Action Indicated (VAI)Documentation (21 CFR 820.100(b))

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
Feb 19, 2025Class IIZ-1267-2025MIM software; System, Image Processing, Radiological
In situations where two images with differing Fields of View (FOV) complete an image fusion, an incorrect, elevated Maximum Standardized…

FDA record score

4 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.

Counted on Nov 15, 2026, method version 1. It counts records and does not judge the site: a low number does not establish that a site is safe, and sites that FDA inspects more often can collect more points. How this is counted.

3 records behind this number
RecordDatePoints x age weightAdds
Class II recall Z-1267-2025, this FEI as the recalling firmFeb 19, 20254 x 14
Inspection classified VAIMar 27, 201510 years or older, so it adds no points0
Inspection classified VAISep 2, 201110 years or older, so it adds no points0

When each source was last refreshed

FDA sources behind this page and when RegDataLab last refreshed each one
RecordsLast refreshedSource as ofStatus
InspectionsNov 15, 2026Newest record Nov 5, 2026Current
Inspection citationsNov 15, 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 15, 2026Newest record Nov 11, 2026Current
Form 483s and inspection documentsNov 13, 2026Newest record Nov 12, 2026Current
Import refusalsNov 15, 2026Newest record Nov 5, 2026Current

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Facility details

Company
MIM Software Inc
Location
Cleveland, OH (US)
Source
device

FDA data resources

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