FDA Inspection
CFS Dental, IncCFS Dental, Inc – FDA Inspection, Dec 4, 2012
Record Details
This FDA Inspection record concerns CFS Dental, Inc, with an inspection on December 4, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- CFS Dental, Inc
- Inspection Date
- December 4, 2012
- Product Type
- Devices
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ID · e0d31d2c-bc11-431e-a40a-6d995642b5a0
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 809882
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
9- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of CFS Dental, Inc
5| Date | Classification | Office | Project area |
|---|---|---|---|
| October 31, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| September 8, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| November 15, 2017 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| April 13, 2015 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 14, 2013 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for CFS Dental, Inc
- FDA Inspection 1221522 - 2023-10-31
- FDA Inspection 1179234 - 2022-09-08
- FDA Inspection 1041342 - 2017-11-15
- FDA Inspection 922056 - 2015-04-13
- FDA Inspection 843938 - 2013-08-14
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