ISOMEDIX OPERATIONS INC. — FDA Facility Profile

FEI 2245304

ISOMEDIX OPERATIONS INC. is an FDA-registered facility (FEI 2245304) located in WHIPPANY, NJ, US. RegDataLab tracks 12 FDA inspections at this facility.

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What FDA found at this site

Latest inspection
May 8, 2025: No Action Indicated (NAI)
Inspections on record
12 (1 VAI, 11 NAI)
Last OAI inspection
None on record
Warning letters
None matched to this FEI. Many letters do not state an FEI: search warning letters by company name

A Form 483 lists an inspector's observations. OAI means FDA recommends regulatory and/or administrative action. A warning letter is FDA's formal enforcement notice. No record here does not establish that a site is safe. Check this site on FDA's Data Dashboard.

Inspections and what FDA cited

Showing the 10 most recent of 12 inspections. Citations are the inspector observations FDA publishes for the inspection.

DateResultWhat FDA cited
May 8, 2025No Action Indicated (NAI)No citations listed
Aug 29, 2024No Action Indicated (NAI)No citations listed
Nov 1, 2022No Action Indicated (NAI)No citations listed
Oct 29, 2018Voluntary Action Indicated (VAI)Written records kept in individual logs (21 CFR 211.182)
Mar 13, 2017No Action Indicated (NAI)No citations listed
Feb 12, 2015No Action Indicated (NAI)No citations listed
Apr 8, 2014No Action Indicated (NAI)No citations listed
Jul 30, 2013No Action Indicated (NAI)No citations listed
Jun 19, 2012No Action Indicated (NAI)No citations listed
Aug 4, 2011No Action Indicated (NAI)No citations listed

Facility details

Company
Isomedix Operations, Inc.
Location
WHIPPANY, NJ (US)
Source
device

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.