FDA-Inspected Site

Wells Enterprises, Inc.

17 FDA inspections are on record for Wells Enterprises, Inc. in Dunkirk, United States.

Clean· No action indicated

Dunkirk, United States · Last updated July 9, 2026

Overview

  • 17 FDA inspections are on record.
  • 5 inspections produced a Form 483.
  • The most recent recorded inspection date is 2024-08-02.

At a glance

Inspections

17

Form 483s

5

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
30 Jul 2024 – 2 Aug 2024Foods & CosmeticsClean
7 Dec 2021 – 16 Dec 2021Foods & CosmeticsClean
7 Dec 2021 – 10 Dec 2021Foods & CosmeticsClean
9 Mar 2020 – 18 Mar 2020Foods & Cosmetics483View 483 →
3 Jun 2019 – 26 Jun 2019Foods & Cosmetics483View 483 →
4 Jun 2018 – 15 Jun 2018Foods & Cosmetics483View 483 →
13 Jun 2017 – 12 Jul 2017Foods & Cosmetics483View 483 →
14 Oct 2015 – 16 Oct 2015Foods & CosmeticsClean
14 Jul 2014 – 15 Jul 2014Foods & CosmeticsClean
23 Aug 2011Not recorded483View 483 →
19 Apr 2011Not recordedClean
31 Jan 2011Not recordedClean

Observations on record

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

18 Mar 2020
21 CFR 117.145(a)

Sanitation Controls Monitoring Proced: Establish Implement

Cited by Elizabeth H Davis, Joel R Merriman, Christopher S Fields

26 Jun 2019
21 CFR 117.145(a)

Process Controls Monitoring Procedures: Establish Implement

Cited by Wendy M Stone, Elizabeth H Davis, Kyle J Spencer

26 Jun 2019
21 CFR 117.145(a)

Sanitation Controls Monitoring Proced: Establish Implement

Cited by Wendy M Stone, Elizabeth H Davis, Kyle J Spencer

26 Jun 2019
21 CFR 117.415(a)(2)

Supply-Chain Appropriate Verification Activities

Cited by Wendy M Stone, Elizabeth H Davis, Kyle J Spencer

15 Jun 2018
21 CFR 117.405(a)(1)

Supply-Chain Program Establish and Implement

Cited by Wendy M Stone, Elizabeth H Davis, Joel R Merriman

Investigators

FDA investigators tied to this site in the record.

Diamond M Oden2 insp.
James D Bridges1 insp.
Joyce A Williams1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 117.145(a)Cited across public-safe Form 483 observations5x
21 CFR 117.150(a)(1)Cited across public-safe Form 483 observations2x
21 CFR 117.165(b)Cited across public-safe Form 483 observations2x
21 CFR 117.20(a)Cited across public-safe Form 483 observations2x
21 CFR 117.35(a)Cited across public-safe Form 483 observations2x
21 CFR 117.35(b)(2)Cited across public-safe Form 483 observations2x
21 CFR 117.40Cited across public-safe Form 483 observations2x
21 CFR 117.80(c)Cited across public-safe Form 483 observations2x
21 CFR 110.37(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.40(a)Cited across public-safe Form 483 observations1x
21 CFR 110.80Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 117.405(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 117.415(a)(2)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Wells Enterprises, Inc.'s 5 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