FDA Inspection 600665 — Dental Technologies, Inc.
The FDA completed an inspection of Dental Technologies, Inc. on July 27, 2009 in Lincolnwood, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- July 27, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lincolnwood, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3291 | 21 CFR 820.100(b) | Procedures |
| 3302 | 21 CFR 820.100(a)(3) | Identifying corrective & preventive actions |