FDA Inspection
CeraSys IncorporatedCeraSys Incorporated – FDA Inspection, Oct 29, 2008
Record Details
This FDA Inspection record concerns CeraSys Incorporated, with an inspection on October 29, 2008, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- CeraSys Incorporated
- Inspection Date
- October 29, 2008
- Product Type
- Devices
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ID · 6268b21a-689b-48b5-9e65-4affcf5a6d7f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 545672
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.198(a)General
- 21 CFR 820.20Management responsibility
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.70(a)Process control procedures
- 21 CFR 820.181(a)DMR device specifications
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of CeraSys Incorporated
2| Date | Classification | Office | Project area |
|---|---|---|---|
| January 17, 2012 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 3, 2010 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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