FDA Inspection
Therakos, Inc.Therakos, Inc. – FDA Inspection, Apr 22, 2015
Record Details
This FDA Inspection record concerns Therakos, Inc., with an inspection on April 22, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Therakos, Inc.
- Inspection Date
- April 22, 2015
- Product Type
- Devices
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ID · 82178888-d63e-4119-a0a1-d7dc5231778e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 925292
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.198(d)Records of MDR Investigation
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
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Other FDA inspections of Therakos, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 7, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| February 3, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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