661054
Dentlight Inc — FEI 3005515469
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 26, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Plano, TX (United States)
Citations
| ID | CFR | Description |
|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 2328 | 21 CFR 820.22 | Quality audits - auditor independence |
| 2630 | 21 CFR 820.30(e) | Design review - documentation |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |