Company
United StatesAthena GTX Inc., Johnston, IA – FDA Inspections
Inspection records and compliance data for Athena GTX Inc. in Johnston, Iowa. 4 FDA inspections on record, last inspected March 07, 2024.
Company Profile
This profile covers Athena GTX Inc. based in Johnston, Iowa, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected May 24, 2012. Last inspected March 7, 2024.
Most cited issue areas
- Lack/Inad procedure-Monitoring/Control of Validated Proces1 inspection
- Lack of or inadequate complaint procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 7, 2024 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1233408 |
| April 21, 2022 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1167863 |
| June 27, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 885248 |
| May 24, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 783157 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Athena GTX Inc.
FEI Number
3007413079
Address
5900 Nw 86th St Ste 300, Johnston, Iowa 50131, United States
Country
United States
ID: cb6c65cb-d494-4822-be0d-e7e39e1e652e