FDA Inspection 681145 — Ivoclar Vivadent Manufacturing GmbH
The FDA completed an inspection of Ivoclar Vivadent Manufacturing GmbH on Aug 5, 2010 in Burs. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 5, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Burs (Austria)
Citations
| ID | CFR | Description |
|---|---|---|
| 3264 | 21 CFR 820.250(b) | Sampling methods - Lack of or inadequate procedures |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |