FDA-Inspected Site

Guard Medical Inc

2 FDA inspections are on record for Guard Medical Inc in Miami, United States.

Clean· No action indicated

Miami, United States · Last updated July 11, 2026

Overview

  • 2 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2025-01-15.

At a glance

Inspections

2

Form 483s

1

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
13 Jan 2025 – 15 Jan 2025Medical Devices & Rad HealthClean
16 Dec 2022 – 19 Dec 2022Medical Devices & Rad Health483View 483 →

Observations on record

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

19 Dec 2022
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Ronald Ifraimov

19 Dec 2022
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Ronald Ifraimov

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.198(a)Cited across public-safe Form 483 observations2x

Full site report

Get the verbatim findings behind Guard Medical Inc's 1 Form 483

Source PDFs and 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