FDA Inspection 1234795 — 3D Smile USA Inc
The FDA completed an inspection of 3D Smile USA Inc on Mar 29, 2024 in New York, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 29, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- New York, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |