FDA Inspection 963088 — Neodontics Inc
The FDA completed an inspection of Neodontics Inc on March 10, 2016 in Sun Valley, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 10, 2016
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Sun Valley, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |