FDA Inspection
CeraSys IncorporatedCeraSys Incorporated – FDA Inspection, May 3, 2010
Record Details
This FDA Inspection record concerns CeraSys Incorporated, with an inspection on May 3, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- CeraSys Incorporated
- Inspection Date
- May 3, 2010
- Product Type
- Devices
View Company Profile
ID · c5fdbbcf-6fa1-4ee9-ba9a-647ea7e2c573
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 661480
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: 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 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
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 |
| 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.