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Isomedix Operations Inc

Sterile processing · Libertyville, IL

FDA recordFDA directory updated Jul 21, 2026Profile not yet claimed9 registered company locations
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Potential fit

Listed operations

The U.S. Food and Drug Administration (FDA) record lists broad activities for this site. Confirm specific services and availability directly.

Sterilize
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Regulatory record at a glance

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Registration record
Current FDA registration record

Expires Dec 31, 2026 · checked Jul 21, 2026

Latest matched inspection
No action indicated (NAI)

Sep 17, 2025 · No conditions warranted FDA action in this inspection.

Matched compliance actions
Past action on file · 2014

More than five years old · review later records.

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Shows

Registration status and a latest matched no action indicated inspection.

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Method and source details
View full inspection and compliance history35 inspection records

FDA inspection history

35 records, Dec 2009 – Sep 2025 · 19 NAI · 14 VAI · 2 OAI

DateClassProject areaCitationsFY
Sep 17, 2025NAIDrug Quality Assurance—2025
Sep 19, 2024NAIPostmarket Assurance: Devices—2024
Sep 19, 2024NAICompliance: Devices—2024
Feb 7, 2020NAIDrug Quality Assurance—2020
Nov 30, 2017NAIBioresearch Monitoring—2018
Nov 30, 2017NAICompliance: Devices—2018
Nov 15, 2016NAIHuman Cellular, Tissue, and Gene Therapies—2017
Feb 5, 2015VAIHuman Cellular, Tissue, and Gene Therapies—2015
Feb 5, 2015VAIDrug Quality Assurance—2015
Feb 5, 2015VAICompliance: Devices—2015
Feb 5, 2015VAIMonitoring of Marketed Animal Drugs, Feed, and Devices—2015
Feb 5, 2015NAIPostmarket Assurance: Devices—2015
Feb 5, 2015VAIFoodborne Biological Hazards—2015
Jan 8, 2014VAIHuman Cellular, Tissue, and Gene Therapies—2014
Jan 8, 2014VAIDrug Quality Assurance—2014
Jan 8, 2014OAICompliance: Devices—2014
Jan 8, 2014VAIFoodborne Biological Hazards—2014
Jan 8, 2014OAIBioresearch Monitoring—2014
Jan 29, 2013VAIColors and Cosmetics TechnologyYes2013
Jan 29, 2013VAIFoodborne Biological HazardsYes2013
Jan 29, 2013VAIMonitoring of Marketed Animal Drugs, Feed, and DevicesYes2013
Jan 29, 2013VAIFood Composition, Standards, Labeling and EconYes2013
Jan 29, 2013VAICompliance: DevicesYes2013
Jan 29, 2013VAIDrug Quality AssuranceYes2013
Sep 13, 2012NAIHuman Cellular, Tissue, and Gene Therapies—2012
Sep 13, 2012NAIDrug Quality Assurance—2012
Sep 13, 2012NAICompliance: Devices—2012
Sep 13, 2012NAIMonitoring of Marketed Animal Drugs, Feed, and Devices—2012
Dec 21, 2010NAIColors and Cosmetics Technology—2011
Dec 21, 2010NAIMonitoring of Marketed Animal Drugs, Feed, and Devices—2011
Dec 21, 2010NAIHuman Cellular, Tissue, and Gene Therapies—2011
Dec 21, 2010NAIDrug Quality Assurance—2011
Dec 21, 2010NAICompliance: Devices—2011
Dec 15, 2009NAIMonitoring of Marketed Animal Drugs, Feed, and Devices—2010
Dec 15, 2009NAIDrug Quality Assurance—2010

No action indicated (NAI) · Voluntary action indicated (VAI) · Official action indicated (OAI)

Matched compliance actions

May 22, 2014Warning Letter · CDRH
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