Company
United StatesIsomedix Operations, Inc., Libertyville, IL – FDA Inspections
Inspection records and compliance data for Isomedix Operations, Inc. in Libertyville, Illinois. 11 FDA inspections on record (1 OAI), last inspected September 17, 2025.
Company Profile
This profile covers Isomedix Operations, Inc. based in Libertyville, Illinois, United States.
FDA Inspection History
- FDA inspections
- 11
- OAI
- 1
- VAI
- 2
- NAI
- 7
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected December 15, 2009. Last inspected September 17, 2025.
Most cited issue areas
- Extent of discrepancy, failure investigations1 inspection
FDA inspections (11)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 17, 2025 | NAI | Human Drugs · Drug Quality Assurance | 1286590 |
| September 19, 2024 | Not classified | Medical Devices & Rad Health | 1250741 |
| February 7, 2020 | NAI | Human Drugs · Drug Quality Assurance | 1121544 |
| November 30, 2017 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1037072 |
| November 15, 2016 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 993210 |
| February 5, 2015 | VAI | Animal Drugs & Feeds, Biologics, Foods & Cosmetics, Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance | 919378 |
| January 8, 2014 | OAI | Biologics, Foods & Cosmetics, Human Drugs, Medical Devices & Rad Health · Compliance: Devices | 862829 |
| January 29, 2013 | VAI | Animal Drugs & Feeds, Foods & Cosmetics, Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance | 816872 |
| September 13, 2012 | NAI | Animal Drugs & Feeds, Biologics, Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance | 798634 |
| December 21, 2010 | NAI | Animal Drugs & Feeds, Biologics, Foods & Cosmetics, Human Drugs, Medical Devices & Rad Health · Monitoring of Marketed Animal Drugs, Feed, and Devices | 702789 |
| December 15, 2009 | NAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 633288 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Isomedix Operations, Inc.
FEI Number
1450662
Address
1880 Industrial Dr, Libertyville, Illinois 60048, United States
Country
United States
ID: e7c353f5-8c18-4dfb-acc9-1b1020c6a7eb