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IMAGING BIOMETRICS, LLC FDA Inspection Record

FEI 3007225492 · Inspections, Form 483s, warning letters and import refusals

IMAGING BIOMETRICS, LLC is an FDA-registered facility (FEI 3007225492) located in Elm Grove, WI, US. RegDataLab tracks 6 FDA inspections at this facility.

What FDA found at this site

Latest inspection
Mar 17, 2025: No Action Indicated (NAI)
Inspections on record
6 (3 VAI, 3 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

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 17, 2025No Action Indicated (NAI)No citations listed
Jun 9, 2022No Action Indicated (NAI)No citations listed
Oct 12, 2018Voluntary Action Indicated (VAI)Design changes - Lack of or Inadequate Procedures (21 CFR 820.30(i))
Records of complaint investigation (21 CFR 820.198(e))
Lack of System for Determining MDR Events (21 CFR 803.17(a)(2))
Mar 22, 2013Voluntary Action Indicated (VAI)Lack of or inadequate complaint procedures (21 CFR 820.198(a))
Records of complaint investigation (21 CFR 820.198(e))
Justification for not reporting (21 CFR 806.20(b)(4))
Lack of Written MDR Procedures (21 CFR 803.17)
Jun 24, 2010No Action Indicated (NAI)No citations listed
Sep 30, 2009Voluntary Action Indicated (VAI)Design transfer - Lack of or inadequate procedures (21 CFR 820.30(h))
Management review accomplishment (21 CFR 820.20(c))

FDA record score

2 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 14, 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
Inspection classified VAIOct 12, 20186 x 0.251.5
Inspection classified VAIMar 22, 201310 years or older, so it adds no points0
Inspection classified VAISep 30, 200910 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 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
Imaging Biometrics LLC
Location
Elm Grove, WI (US)
Source
device

FDA data resources

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