FDA Inspection 707865 — DiamoDent, Inc.
The FDA completed an inspection of DiamoDent, Inc. on Jan 12, 2011 in Dana Point, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jan 12, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Dana Point, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3193 | 21 CFR 820.30(g) | Design validation - simulated testing |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |