FDA Inspection
Athena GTX Inc.Athena GTX Inc. – FDA Inspection, Apr 21, 2022
Record Details
This FDA Inspection record concerns Athena GTX Inc., with an inspection on April 21, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Athena GTX Inc.
- Inspection Date
- April 21, 2022
- Product Type
- Devices
View Company Profile
ID · f42d0e60-cc72-430c-9170-6a7a3114b83d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1167863
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Athena GTX Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 7, 2024 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 27, 2014 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 24, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Athena GTX Inc.
- FDA Inspection 1233408 - 2024-03-07
- FDA Inspection 885248 - 2014-06-27
- FDA Inspection 783157 - 2012-05-24
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