FDA Inspection 872111 — Ottawa Dental Laboratory Ltd
The FDA completed an inspection of Ottawa Dental Laboratory Ltd on April 2, 2014 in Ottawa, 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
- April 2, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Ottawa, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3199 | 21 CFR 820.40(a) | Document review, approval documentation |
| 3668 | 21 CFR 820.20(c) | Management review dates |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |