FDA Inspection
Therakos, Inc.Therakos, Inc. – FDA Inspection, Feb 3, 2011
Record Details
This FDA Inspection record concerns Therakos, Inc., with an inspection on February 3, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Therakos, Inc.
- Inspection Date
- February 3, 2011
- Product Type
- Devices
View Company Profile
ID · 89d68591-2ce9-4ac6-afec-b64d124f0fb0
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 709617
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
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Other FDA inspections of Therakos, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| April 22, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 7, 2014 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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