FDA Inspection
Ivoclar Vivadent Manufacturing GmbHIvoclar Vivadent Manufacturing GmbH – FDA Inspection, Aug 5, 2010
Record Details
This FDA Inspection record concerns Ivoclar Vivadent Manufacturing GmbH, with an inspection on August 5, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- August 5, 2010
- Product Type
- Devices
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ID · 3189a45d-d532-4567-aab9-b591faec2763
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 681145
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
2- 21 CFR 820.70(b)Production and Process Change Procedures, lack of or Inad.
- 21 CFR 820.250(b)Sampling methods - Lack of or inadequate procedures
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Other FDA inspections of Ivoclar Vivadent Manufacturing GmbH
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 6, 2018 | Not classified | Office of Inspections and Investigations | |
| August 26, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Ivoclar Vivadent Manufacturing GmbH
- FDA Inspection 1124028 - 2018-09-06
- FDA Inspection 988687 - 2016-08-26
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