Company
United StatesIsomedix Operations, Inc., Libertyville, IL – FDA Inspections
Inspection records and compliance data for Isomedix Operations, Inc. in Libertyville, Illinois. 9 FDA inspections on record, 2 Form 483s, last inspected January 27, 2026.
Company Profile
This profile covers Isomedix Operations, Inc. based in Libertyville, Illinois, United States.
FDA Inspection History
- FDA inspections
- 9
- OAI
- 0
- VAI
- 2
- NAI
- 6
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected June 24, 2009. Last inspected January 27, 2026.
Most cited issue areas
- Documentation of maintenance and cleaning1 inspection
- Procedures to meet core CTGP1 inspection
- Production processes1 inspection
FDA inspections (9)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 27, 2026 | Not classified | Biologics · Human Cellular, Tissue, and Gene Therapies | 1300188 |
| September 23, 2024 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1250815 |
| September 18, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1219550 |
| January 9, 2017 | NAI | Biologics · Human Cellular, Tissue, and Gene Therapies | 998533 |
| December 3, 2015 | VAI | Animal Drugs & Feeds, Biologics, Foods & Cosmetics, Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance | 943630 |
| September 28, 2012 | NAI | Biologics, Foods & Cosmetics, Human Drugs, Medical Devices & Rad Health · Foodborne Biological Hazards | 800833 |
| January 24, 2011 | NAI | Animal Drugs & Feeds, Biologics, Foods & Cosmetics, Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance | 707167 |
| December 2, 2009 | NAI | Animal Drugs & Feeds, Human Drugs · Monitoring of Marketed Animal Drugs, Feed, and Devices | 633285 |
| June 24, 2009 | NAI | Animal Drugs & Feeds, Foods & Cosmetics, Human Drugs, Medical Devices & Rad Health · Compliance: Devices | 592800 |
FDA documents
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Company Information
Name
Isomedix Operations, Inc.
FEI Number
3003015552
Address
2500 Commerce Dr, Libertyville, Illinois 60048, United States
Country
United States
ID: a557725b-37c3-405c-bfbb-01da7749846c