Company
United StatesIsomedix Operations, Inc., Grand Prairie, TX – FDA Inspections
Inspection records and compliance data for Isomedix Operations, Inc. in Grand Prairie, Texas. 4 FDA inspections on record (1 OAI), 1 Form 483, last inspected June 05, 2025.
Company Profile
This profile covers Isomedix Operations, Inc. based in Grand Prairie, Texas, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 1
- VAI
- 1
- NAI
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected June 21, 2010. Last inspected June 5, 2025.
Most cited issue areas
- Lack of or inadequate final acceptance procedures1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 5, 2025 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1272796 |
| August 23, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1063030 |
| May 10, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 724485 |
| June 21, 2010 | OAI | Medical Devices & Rad Health · Compliance: Devices | 668460 |
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
3002681132
Address
1175 Isuzu Pkwy, Grand Prairie, Texas 75050, United States
Country
United States
ID: 13e21b6d-d030-45ef-985e-e9c653eee0ff