Company
United StatesSterigenics US, LLC, Willowbrook, IL – FDA Inspections
Inspection records and compliance data for Sterigenics US, LLC in Willowbrook, Illinois. 7 FDA inspections on record, 2 Form 483s, last inspected February 28, 2025.
Company Profile
This profile covers Sterigenics US, LLC based in Willowbrook, Illinois, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 2
- NAI
- 5
- Form 483s
- 2
- Warning letters
- 0
First inspected March 18, 2009. Last inspected February 28, 2025.
Most cited issue areas
- Activity documentation1 inspection
- Adjustment1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| February 28, 2025 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1265113 |
| July 6, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1017915 |
| April 7, 2017 | VAI | Foods & Cosmetics, Human Drugs, Medical Devices & Rad Health · Bioresearch Monitoring | 1013355 |
| February 11, 2015 | NAI | Animal Drugs & Feeds, Foods & Cosmetics, Human Drugs, Medical Devices & Rad Health · Foodborne Biological Hazards | 913117 |
| November 26, 2012 | NAI | Animal Drugs & Feeds, Foods & Cosmetics, Human Drugs, Medical Devices & Rad Health · Postmarket Assurance: Devices | 809586 |
| October 7, 2011 | NAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 745140 |
| March 18, 2009 | VAI | Animal Drugs & Feeds, Foods & Cosmetics, Human Drugs, Medical Devices & Rad Health · Foodborne Biological Hazards | 570531 |
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
Sterigenics US, LLC
FEI Number
1450293
Address
7775 S Quincy St, Willowbrook, Illinois 60527, United States
Country
United States
ID: efb8437a-1a68-4123-ab23-926a04c421d6