Atlas

FDA-Inspected Site

American Thermal Instruments Inc

6 FDA inspections are on record for American Thermal Instruments Inc in Moraine, United States.

Clean· No action indicated

Moraine, United States · Last updated July 10, 2026

Overview

  • 6 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2023-10-20.

At a glance

Inspections

6

Form 483s

3

EIRs

1

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
17 Oct 2023 – 20 Oct 2023Medical Devices & Rad HealthClean
23 Feb 2022 – 14 Mar 2022Medical Devices & Rad Health483View 483 →
20 Feb 2018 – 1 Mar 2018Medical Devices & Rad Health483View 483 →
14 Mar 2011Not recorded483On file
27 Apr 2005Not recordedClean
3 Mar 2004Not recordedClean

Observations on record

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

14 Mar 2022
21 CFR 820.184

Lack of or inadequate DHR procedures

Cited by Javonica F Penn

14 Mar 2022
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Javonica F Penn

14 Mar 2022
21 CFR 820.30(c)

Design input - Lack of or inadequate procedures

Cited by Javonica F Penn

14 Mar 2022
21 CFR 820.50

Purchasing controls, Lack of or inadequate procedures

Cited by Javonica F Penn

14 Mar 2022
21 CFR 820.70(a)

Production processes

Cited by Javonica F Penn

Investigators

FDA investigators tied to this site in the record.

Javonica F Penn2 insp.
Amber M Capello-Jones1 insp.
Allison M Scheck1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.70(a)Cited across public-safe Form 483 observations3x
21 CFR 820.100(a)Cited across public-safe Form 483 observations2x
21 CFR 820.181Cited across public-safe Form 483 observations2x
21 CFR 820.50(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 820.50(b)Cited across public-safe Form 483 observations2x
21 CFR 820.184Cited across public-safe Form 483 observations1x
21 CFR 820.198(a)Cited across public-safe Form 483 observations1x
21 CFR 820.30(c)Cited across public-safe Form 483 observations1x
21 CFR 820.50Cited across public-safe Form 483 observations1x
21 CFR 820.75(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind American Thermal Instruments Inc's 3 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