FDA Inspection 600289 — Dentium USA
The FDA completed an inspection of Dentium USA on Jul 21, 2009 in Cypress, CA. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jul 21, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Cypress, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2351 | 21 CFR 820.25(b) | Training |
| 2628 | 21 CFR 820.30(e) | Design review procedures - personnel |
| 3164 | 21 CFR 820.184(d) | Acceptance records |
| 4189 | 21 CFR 820.198(a) | General |