FDA Inspection 1290296 — Drake Precision Dental Laboratory
The FDA completed an inspection of Drake Precision Dental Laboratory on November 5, 2025 in Charlotte, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 5, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Charlotte, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3159 | 21 CFR 820.184 | DHR content |
| 3171 | 21 CFR 820.198(b) | Rationale documented for no investigation |
| 3173 | 21 CFR 820.198(d) | Evaluation, timeliness, identification |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3345 | 21 CFR 820.200(a) | Servicing - Lack of or inadequate procedures |
| 3432 | 21 CFR 820.75(b)(2) | Documentation of validated process performance |
| 3665 | 21 CFR 820.20(b)(3) | Management representative |
| 3696 | 21 CFR 820.100(b) | Documentation |