FDA Inspection 1063106 — Viax Dental Lab
The FDA completed an inspection of Viax Dental Lab on Aug 23, 2018 in Alajuela. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 23, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Alajuela (Costa Rica)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 5171 | 21 CFR 1040.10(g)(3) | Class IV "Danger" label |