Company
AustriaIvoclar Vivadent Manufacturing GmbH, Burs, Austria – FDA Inspections
Inspection records and compliance data for Ivoclar Vivadent Manufacturing GmbH in Burs. 3 FDA inspections on record, 1 Form 483, last inspected September 06, 2018.
Company Profile
This profile covers Ivoclar Vivadent Manufacturing GmbH based in Burs, Austria.
FDA Inspection History
- FDA inspections
- 3
- OAI
- 0
- VAI
- 1
- NAI
- 1
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected August 5, 2010. Last inspected September 6, 2018.
Most cited issue areas
- Production and Process Change Procedures, lack of or Inad.1 inspection
- Sampling methods - Lack of or inadequate procedures1 inspection
FDA inspections (3)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 6, 2018 | Not classified | Medical Devices & Rad Health | 1124028 |
| August 26, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 988687 |
| August 5, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 681145 |
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 Manufacturing GmbH
FEI Number
1000493628
Address
Bremschlstrase 16, Burs, Austria
Country
Austria
ID: 0c03d131-9542-41ee-9f11-aeffe1061fe3