Company
United StatesIsomedix Operations Inc., Coon Rapids, MN – FDA Inspections
Inspection records and compliance data for Isomedix Operations Inc. in Coon Rapids, Minnesota. 8 FDA inspections on record, 2 Form 483s, last inspected July 17, 2026.
Company Profile
This profile covers Isomedix Operations Inc. based in Coon Rapids, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 2
- NAI
- 4
- Unclassified
- 2
- Form 483s
- 2
- Warning letters
- 0
First inspected July 1, 2010. Last inspected July 17, 2026.
Most cited issue areas
- Procedures for analysis of data not documented1 inspection
- Production controls not adequate1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 17, 2026 | Not classified | Medical Devices & Rad Health · Project Evaluation: Devices | 1327498 |
| January 26, 2024 | Not classified | Medical Devices & Rad Health | 1231745 |
| September 15, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1217934 |
| July 17, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1060499 |
| April 13, 2016 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 966619 |
| January 14, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 863123 |
| October 20, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 750179 |
| July 1, 2010 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 670424 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Isomedix Operations Inc.
FEI Number
2183744
Address
380 90th Ave Nw, Coon Rapids, Minnesota 55433, United States
Country
United States
ID: 1ee57dd6-50ff-4795-baee-5e6e2feb47e6