FDA Inspection 1218157 — Sun Dental Laboratories, LLC
The FDA completed an inspection of Sun Dental Laboratories, LLC on September 20, 2023 in Saint Petersburg, FL. 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
- September 20, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Saint Petersburg, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 21424 | 21 CFR 820.120(b) | Labeling inspection - UDI |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |