Company
SwitzerlandColtene /Whaledent AG, Altstatten Sg, Switzerland – FDA Inspections
Inspection records and compliance data for Coltene /Whaledent AG in Altstatten Sg. 2 FDA inspections on record, last inspected September 19, 2013.
Company Profile
This profile covers Coltene /Whaledent AG based in Altstatten Sg, Switzerland.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 2
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
First inspected December 9, 2010. Last inspected September 19, 2013.
Most cited issue areas
- DHR content1 inspection
- Lack of or inadequate procedures for labeling1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 19, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 849198 |
| December 9, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 704248 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Coltene /Whaledent AG
FEI Number
3002806620
Address
Feldwiesenstrasse 20, Altstatten Sg, Switzerland
Country
Switzerland
ID: 2bc6b18d-ce8d-4302-a081-ae64499f6996