Atlas

FDA-Inspected Site

Tom's of Maine, Inc.

8 FDA inspections are on record for Tom's of Maine, Inc. in Sanford, United States.

483· Form 483 issued

Sanford, United States · Last updated July 10, 2026

Overview

  • 8 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2024-05-22.

At a glance

Inspections

8

Form 483s

4

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
7 May 2024 – 22 May 2024Human DrugsWLOn file
15 Mar 2021 – 19 Mar 2021Human DrugsClean
18 Jul 2017 – 19 Jul 2017Medical Devices & Rad HealthClean
13 Jun 2016 – 17 Jun 2016Human Drugs483View 483 →
2 Apr 2013 – 5 Apr 2013Human Drugs483On file
10 Apr 2009Not recorded483View 483 →
13 Sep 2007Not recordedClean
13 Mar 2002Not recordedClean

Observations on record

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

17 Jun 2016
21 CFR 211.113(a)

Procedures for non-sterile drug products

Cited by Edmund F Mrak

17 Jun 2016
21 CFR 211.160(b)(3)

Drug products - samples representative, identified properly

Cited by Edmund F Mrak

17 Jun 2016
21 CFR 211.25(a)

Training--operations, GMPs, written procedures

Cited by Edmund F Mrak

17 Jun 2016
21 CFR 211.56(a)

Sanitation--buildings not clean, free of infestation

Cited by Edmund F Mrak

10 Apr 2009
21 CFR 211.182

Specific information required in individual logs

Cited by Laurie B Frazier

Investigators

FDA investigators tied to this site in the record.

Edmund F Mrak3 insp.
Lori M Newman1 insp.
James W Whitney1 insp.
Jason B Prosser1 insp.
Laurie B Frazier1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.113(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.182Cited across public-safe Form 483 observations1x
21 CFR 211.188(a)Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.198(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 211.204Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.56(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Tom's of Maine, Inc.'s 4 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