Atlas

FDA-Inspected Site

Isomedix Operations, Inc.

14 FDA inspections are on record for Isomedix Operations, Inc. in Whippany, United States.

Clean· No action indicated

Whippany, United States · Last updated July 9, 2026

Overview

  • 14 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2025-05-08.

At a glance

Inspections

14

Form 483s

1

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
7 May 2025 – 8 May 2025Human DrugsClean
27 Aug 2024 – 29 Aug 2024BiologicsClean
27 Oct 2022 – 1 Nov 2022Medical Devices & Rad HealthClean
23 Oct 2018 – 29 Oct 2018Human Drugs483View 483 →
9 Mar 2017 – 13 Mar 2017Medical Devices & Rad HealthClean
10 Feb 2015 – 12 Feb 2015Foods & CosmeticsClean
4 Apr 2014 – 8 Apr 2014Human DrugsClean
29 Jul 2013 – 30 Jul 2013BiologicsClean
19 Jun 2012Not recordedClean
4 Aug 2011Not recordedClean
1 Jul 2010Not recordedClean
16 Jan 2009Not recordedClean

Observations on record

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

29 Oct 2018
21 CFR 211.182

Written records kept in individual logs

Cited by Yvesna C Blaise

Investigators

FDA investigators tied to this site in the record.

Christina N Maurino2 insp.
Annet R Rajan1 insp.
Suchan Kim1 insp.
Emily A Walters1 insp.
Colin E Tack1 insp.
Yvesna C Blaise1 insp.
Jose M Cayuela1 insp.
Esteban Beltran1 insp.
Gobiga Vanniyasingam1 insp.
Charles Chacko1 insp.
Alberto A Viciedo1 insp.
David H Smith1 insp.
Douglas C Kovacs1 insp.
Lisa Mathew1 insp.
Robert G Ruff1 insp.
Erin D Mccaffery1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.182Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Isomedix Operations, Inc.'s 1 Form 483

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