FDA-Inspected Site

Advance Medical Designs, Inc.

8 FDA inspections are on record for Advance Medical Designs, Inc. in Marietta, United States.

Clean· No action indicated

Marietta, United States · Last updated August 15, 2026

Overview

  • 8 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2026-02-13.

At a glance

Inspections

8

Form 483s

1

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
9 Feb 2026 – 13 Feb 2026Medical Devices & Rad HealthClean
26 Jun 2023 – 30 Jun 2023Medical Devices & Rad Health483View 483 →
26 Jul 2018Medical Devices & Rad HealthClean
13 Dec 2016 – 15 Dec 2016Medical Devices & Rad HealthClean
13 Jan 2014 – 15 Jan 2014Medical Devices & Rad HealthClean
16 Jun 2010Not recordedClean
31 Aug 2005Not recordedClean
11 Feb 2000Not recordedClean

Observations on record

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

30 Jun 2023
21 CFR 820.181

DMR - not or inadequately maintained

Cited by Inga M Warr

30 Jun 2023
21 CFR 820.181

DMR - not or inadequately maintained

Cited by Inga M Warr

30 Jun 2023
21 CFR 820.30(e)

Design review - Lack of or inadequate procedures

Cited by Inga M Warr

30 Jun 2023
21 CFR 820.30(e)

Design review - Lack of or inadequate procedures

Cited by Inga M Warr

30 Jun 2023
21 CFR 820.30(j)

Design history file

Cited by Inga M Warr

Investigators

FDA investigators tied to this site in the record.

Ana L Kewes1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.181Cited across public-safe Form 483 observations2x
21 CFR 820.30(e)Cited across public-safe Form 483 observations2x
21 CFR 820.30(j)Cited across public-safe Form 483 observations2x
21 CFR 820.50(a)Cited across public-safe Form 483 observations2x

Full site report

Get the verbatim findings behind Advance Medical Designs, 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