Atlas

Form 483

Minnetronix, Inc. Form 483, 2026-04-01

FDA issued a Form 483 to Minnetronix, Inc. on 2026-04-01 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Minnetronix, Inc. · Saint Paul, United States · Issued April 1, 2026

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

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

Inspected site

MIMinnetronix, Inc.Saint Paul, United States

Inspection team

CLChristina L Bigham
AUAlicia U Jacobo

Cited regulations

CFR citations associated with this Form 483.

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 483 report

Get the verbatim text of all 2 observations

The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere