FDA Inspection
Cylex, Inc.Cylex, Inc. – FDA Inspection, Dec 17, 2008
Record Details
This FDA Inspection record concerns Cylex, Inc., with an inspection on December 17, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Cylex, Inc.
- Inspection Date
- December 17, 2008
- Product Type
- Devices
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ID · a4e40955-ab65-469c-a651-ce8b47399166
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 552589
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- 21 CFR 820.30(f)Design verification acceptance criteria
- 21 CFR 820.30(d)Essential design outputs
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.70(i)Documentation of software validation
- 21 CFR 820.30(c)Design input approval documentation
- 21 CFR 820.90(b)(1)Documentation of disposition, justification, signature
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Other FDA inspections of Cylex, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 11, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Cylex, Inc.
- FDA Inspection 785785 - 2012-06-11
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