Atlas

FDA-Inspected Site

Guardian Medical USA Inc.

2 FDA inspections are on record for Guardian Medical USA Inc. in Swanton, United States.

483· Form 483 issued

Swanton, United States · Last updated August 15, 2026

Overview

  • 2 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2026-06-02.

At a glance

Inspections

2

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
26 May 2026 – 2 Jun 2026Medical Devices & Rad Health483View 483 →
21 Jun 2022 – 24 Jun 2022Medical Devices & Rad HealthClean

Observations on record

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

2 Jun 2026
ISO 13485:2016 Clause 4.1.2

Risk-based approach not applied to QMS processes

Cited by Felicia E Armbrustmacher

2 Jun 2026
ISO 13485:2016 Clause 7.3.8

Design and development transfer procedures not documented

Cited by Felicia E Armbrustmacher

2 Jun 2026
ISO 13485:2016 Clause 7.4.1

Criteria for the evaluation and selection of suppliers not established

Cited by Felicia E Armbrustmacher

2 Jun 2026
ISO 13485:2016 Clause 7.5.6

Planned results not consistently met during validation of processes

Cited by Felicia E Armbrustmacher

2 Jun 2026
ISO 13485:2016 Clause 8.3.1

Procedure for nonconforming product not documented

Cited by Felicia E Armbrustmacher

Investigators

FDA investigators tied to this site in the record.

Felicia E Armbrustmacher1 insp.
Talmane J Fisher1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
ISO 13485:2016 Clause 4.1.2Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.3.8Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.4.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.5.6Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.3.1Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.5.2Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Guardian Medical USA 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