Company
United StatesIsomedix Operations Inc, Groveport, OH – FDA Inspections
Inspection records and compliance data for Isomedix Operations Inc in Groveport, Ohio. 6 FDA inspections on record, 1 Form 483, last inspected June 17, 2025.
Company Profile
This profile covers Isomedix Operations Inc based in Groveport, Ohio, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 4
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected January 27, 2010. Last inspected June 17, 2025.
Most cited issue areas
- Lack of or inadequate process validation2 inspections
- Complete test data included in records1 inspection
- DHR - not or inadequately maintained1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 17, 2025 | Not classified | Medical Devices & Rad Health | 1276319 |
| July 25, 2022 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1177943 |
| November 30, 2017 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1032396 |
| October 10, 2014 | NAI | Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance | 899490 |
| August 9, 2012 | VAI | Human Drugs, Medical Devices & Rad Health · Drug Quality Assurance | 794210 |
| January 27, 2010 | VAI | Human Drugs, Medical Devices & Rad Health · Compliance: Devices | 644445 |
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
1526711
Address
4405 Marketing Pl, Groveport, Ohio 43125, United States
Country
United States
ID: 2e07a0b3-1a95-443d-8dad-87169998d288