Company
United StatesIvoclar Vivadent, Inc., Amherst, NY – FDA Inspections
Inspection records and compliance data for Ivoclar Vivadent, Inc. in Amherst, New York. 6 FDA inspections on record, 1 Form 483, last inspected January 11, 2018.
Company Profile
This profile covers Ivoclar Vivadent, Inc. based in Amherst, New York, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 3
- NAI
- 3
- Form 483s
- 1
- Warning letters
- 0
First inspected March 9, 2010. Last inspected January 11, 2018.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
- Process control procedures, Lack of or inadequate procedures1 inspection
- Remedial action1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| January 11, 2018 | VAI | Medical Devices & Rad Health · Compliance: Devices | 1037471 |
| June 7, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 836298 |
| December 2, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 759584 |
| November 16, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 754457 |
| February 9, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 710802 |
| March 9, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 650681 |
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
Ivoclar Vivadent, Inc.
FEI Number
1316092
Address
175 Pineview Dr, Amherst, New York 14228, United States
Country
United States
ID: 8cbf5889-296c-4161-a731-d1afeb6d0be2