Atlas

FDA-Inspected Site

Minnetronix, Inc.

10 FDA inspections are on record for Minnetronix, Inc. in Saint Paul, United States.

483· Form 483 issued

Saint Paul, United States · Last updated July 10, 2026

Overview

  • 10 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2026-04-01.

At a glance

Inspections

10

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
23 Mar 2026 – 1 Apr 2026Medical Devices & Rad Health483View 483 →
3 Jun 2025 – 4 Jun 2025Medical Devices & Rad HealthClean
1 Aug 2023 – 8 Aug 2023Medical Devices & Rad HealthClean
6 Dec 2022 – 8 Dec 2022Medical Devices & Rad HealthClean
8 Apr 2019 – 10 Apr 2019Medical Devices & Rad HealthClean
9 May 2017 – 11 May 2017Medical Devices & Rad HealthClean
5 Apr 2016 – 6 Apr 2016Medical Devices & Rad HealthClean
9 Feb 2015 – 11 Feb 2015Medical Devices & Rad HealthClean
21 Oct 2010Not recordedClean
18 Jan 2008Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

1 Apr 2026
ISO 13485:2016 Clause 8.3.1

Procedure for nonconforming product not documented

Cited by Christina L Bigham, Alicia U Jacobo

1 Apr 2026
ISO 13485:2016 Clause 8.4

Procedures for analysis of data not documented

Cited by Christina L Bigham, Alicia U Jacobo

Investigators

FDA investigators tied to this site in the record.

Benjamin W Anderson3 insp.
Ralph W Jerndal2 insp.
Susan M Matthias2 insp.
Christina L Bigham1 insp.
Alicia U Jacobo1 insp.
Jennifer S Ness1 insp.
Marissa S Steinhagen1 insp.
Yehualashe A Gessesse1 insp.
James A Beaulieu1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
ISO 13485:2016 Clause 8.3.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.4Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Minnetronix, Inc.'s 1 Form 483

Recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat