FDA Inspection
CFS Dental, IncCFS Dental, Inc – FDA Inspection, Aug 14, 2013
Record Details
This FDA Inspection record concerns CFS Dental, Inc, with an inspection on August 14, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- CFS Dental, Inc
- Inspection Date
- August 14, 2013
- Product Type
- Devices
View Company Profile
ID · e4beb986-153a-4f04-b7b2-1977a87b4957
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 843938
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
7- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.70(c)Environmental control 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 820.30(j)Design history file
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 |
| December 4, 2012 | OAI | Center for Devices and Radiological Health | Postmarket Assurance: 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 809882 - 2012-12-04
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