1092833
Oralten Corporation — FEI 3011376187
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 13, 2019
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Corona, CA (United States)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2327 | 21 CFR 820.22 | Quality audits - Lack of or inadequate procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |