FDA Inspection
Therakos, Inc.Therakos, Inc. – FDA Inspection, May 7, 2014
Record Details
This FDA Inspection record concerns Therakos, Inc., with an inspection on May 7, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Therakos, Inc.
- Inspection Date
- May 7, 2014
- Product Type
- Devices
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ID · c0cf0458-5b12-47d7-9cf8-9ab048c65dab
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 877892
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 820.80(e)Documentation
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.30(g)Design validation - user needs and intended uses
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(g)Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.181(a)DMR device specifications
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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 |
| February 3, 2011 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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