Company
United StatesIvoclar Vivadent Manufacturing, Inc., Somerset, NJ – FDA Inspections
Inspection records and compliance data for Ivoclar Vivadent Manufacturing, Inc. in Somerset, New Jersey. 4 FDA inspections on record, 1 Form 483, last inspected October 11, 2018.
Company Profile
This profile covers Ivoclar Vivadent Manufacturing, Inc. based in Somerset, New Jersey, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 0
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected January 21, 2009. Last inspected October 11, 2018.
Most cited issue areas
- DHR content1 inspection
- Documentation1 inspection
- Equipment suitability & capability1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| October 11, 2018 | Not classified | Medical Devices & Rad Health | 1121013 |
| September 20, 2017 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1025860 |
| November 22, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 754045 |
| January 21, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 557929 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Ivoclar Vivadent Manufacturing, Inc.
FEI Number
2244842
Address
500 Memorial Dr, Somerset, New Jersey 08873, United States
Country
United States
ID: 84b0f696-b6fb-4268-b763-c6e8fa8edcaa