FDA Inspection
CeraSys IncorporatedCeraSys Incorporated – FDA Inspection, Jan 17, 2012
Record Details
This FDA Inspection record concerns CeraSys Incorporated, with an inspection on January 17, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- CeraSys Incorporated
- Inspection Date
- January 17, 2012
- Product Type
- Devices
View Company Profile
ID · 4335fe16-3861-4781-891a-5b160de27ddc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 770865
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.184Lack of or inadequate DHR procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 803.17(a)(1)Lack of System for Event Evaluations
Full citation text and observation details available on the Dashboard.
Other FDA inspections of CeraSys Incorporated
2| Date | Classification | Office | Project area |
|---|---|---|---|
| May 3, 2010 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 29, 2008 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for CeraSys Incorporated
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.