Atlas

FDA-Inspected Site

Ad-Tech Medical Instrument Corporation

8 FDA inspections are on record for Ad-Tech Medical Instrument Corporation in Oak Creek, United States.

Clean· No action indicated

Oak Creek, United States · Last updated August 15, 2026

Overview

  • 8 FDA inspections are on record.
  • 6 inspections produced a Form 483.
  • The most recent recorded inspection date is 2022-04-07.

At a glance

Inspections

8

Form 483s

6

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
5 Apr 2022 – 7 Apr 2022Medical Devices & Rad HealthClean
15 May 2019 – 27 Jun 2019Medical Devices & Rad Health483View 483 →
28 Aug 2017 – 5 Sep 2017Medical Devices & Rad Health483View 483 →
15 May 2014 – 20 Jun 2014Medical Devices & Rad HealthClean
17 Apr 2013 – 5 Jun 2013Medical Devices & Rad HealthWLView 483 →
26 Nov 2012Not recorded483View 483 →
11 Jan 2012Not recordedWLOn file
24 Feb 2011Not recorded483View 483 →

Observations on record

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

27 Jun 2019
21 CFR 803.17(a)(2)

Lack of System for Determining MDR Events

Cited by Michelle J Glembin

27 Jun 2019
21 CFR 803.50(a)(2)

Individual Report of Malfunction

Cited by Michelle J Glembin

27 Jun 2019
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Michelle J Glembin

27 Jun 2019
21 CFR 820.160(b)

Distribution records

Cited by Michelle J Glembin

27 Jun 2019
21 CFR 820.181

DMR - not or inadequately maintained

Cited by Michelle J Glembin

Investigators

FDA investigators tied to this site in the record.

Michelle J Glembin5 insp.
Ralph W Jerndal1 insp.
Nicholas T Domer1 insp.
Stephen D Eich1 insp.
Nicholas Z Lu1 insp.
Richard J Tucker1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations7x
21 CFR 820.75(a)Cited across public-safe Form 483 observations5x
21 CFR 820.90(a)Cited across public-safe Form 483 observations5x
21 CFR 820.30(g)Cited across public-safe Form 483 observations4x
21 CFR 820.30(i)Cited across public-safe Form 483 observations3x
21 CFR 820.70(c)Cited across public-safe Form 483 observations3x
21 CFR 820.75(c)Cited across public-safe Form 483 observations3x
21 CFR 820.160(b)Cited across public-safe Form 483 observations2x
21 CFR 820.181Cited across public-safe Form 483 observations2x
21 CFR 820.198(a)Cited across public-safe Form 483 observations2x
21 CFR 820.50(a)(3)Cited across public-safe Form 483 observations2x
21 CFR 820.65Cited across public-safe Form 483 observations2x
21 CFR 803.17(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 803.50(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 820.184Cited across public-safe Form 483 observations1x
21 CFR 820.198(c)Cited across public-safe Form 483 observations1x
21 CFR 820.22Cited across public-safe Form 483 observations1x
21 CFR 820.30(c)Cited across public-safe Form 483 observations1x
21 CFR 820.30(d)Cited across public-safe Form 483 observations1x
21 CFR 820.30(h)Cited across public-safe Form 483 observations1x
21 CFR 820.30(j)Cited across public-safe Form 483 observations1x
21 CFR 820.40(a)Cited across public-safe Form 483 observations1x
21 CFR 820.50Cited across public-safe Form 483 observations1x
21 CFR 820.50(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 820.70(b)Cited across public-safe Form 483 observations1x
21 CFR 820.90(b)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Ad-Tech Medical Instrument Corporation's 6 Form 483s

Source PDFs, verbatim observations, 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