Company
United StatesColtene Whaledent Inc, Cuyahoga Falls, OH – FDA Inspections
Inspection records and compliance data for Coltene Whaledent Inc in Cuyahoga Falls, Ohio. 4 FDA inspections on record, last inspected April 20, 2016.
Company Profile
This profile covers Coltene Whaledent Inc based in Cuyahoga Falls, Ohio, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected March 5, 2009. Last inspected April 20, 2016.
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 20, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 967907 |
| May 22, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 836254 |
| January 21, 2010 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 643972 |
| March 5, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 565202 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Coltene Whaledent Inc
FEI Number
2416455
Address
235 Ascot Pkwy, Cuyahoga Falls, Ohio 44223, United States
Country
United States
ID: 57fabb13-22f6-4e55-9ded-4e34f253b89f