FDA Inspection 1165383 — Burbank Dental Lab Inc
The FDA completed an inspection of Burbank Dental Lab Inc on March 11, 2022 in Burbank, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 11, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Burbank, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |