Atlas

FDA-Inspected Site

Guy & O'Neill, Inc.

3 FDA inspections are on record for Guy & O'Neill, Inc. in Fredonia, United States.

483· Form 483 issued

Fredonia, United States · Last updated July 10, 2026

Overview

  • 3 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2021-10-29.

At a glance

Inspections

3

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
20 Oct 2021 – 29 Oct 2021Medical Devices & Rad Health483View 483 →
5 Aug 2019 – 22 Aug 2019Medical Devices & Rad Health483View 483 →
12 Feb 2018 – 20 Feb 2018Human Drugs483On file

Observations on record

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

29 Oct 2021
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Michelle J Glembin, Nicholas T Domer

29 Oct 2021
21 CFR 820.150

Lack of or inadequate procedures for storage.

Cited by Michelle J Glembin, Nicholas T Domer

29 Oct 2021
21 CFR 820.22

Quality audits - Lack of or inadequate procedures

Cited by Michelle J Glembin, Nicholas T Domer

29 Oct 2021
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Michelle J Glembin, Nicholas T Domer

29 Oct 2021
21 CFR 820.90(a)

Nonconforming product, Lack of or inadequate procedures

Cited by Michelle J Glembin, Nicholas T Domer

Investigators

FDA investigators tied to this site in the record.

Michelle J Glembin2 insp.
Nicholas T Domer1 insp.
Sandra A Hughes1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.90(a)Cited across public-safe Form 483 observations5x
21 CFR 820.100(a)Cited across public-safe Form 483 observations4x
21 CFR 820.250(b)Cited across public-safe Form 483 observations4x
21 CFR 820.30(a)Cited across public-safe Form 483 observations4x
21 CFR 820.30(g)Cited across public-safe Form 483 observations4x
21 CFR 803.17Cited across public-safe Form 483 observations3x
21 CFR 820.150Cited across public-safe Form 483 observations1x
21 CFR 820.22Cited 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 Guy & O'Neill, Inc.'s 3 Form 483s

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