FDA Inspection 1168168 — Dentonics, Inc
The FDA completed an inspection of Dentonics, Inc on Apr 28, 2022 in Monroe, NC. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 9 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Apr 28, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Monroe, NC (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 |
| 3235 | 21 CFR 820.72(a) | Equipment control activity documentation |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3699 | 21 CFR 820.160(b) | Distribution records |
| 447 | 21 CFR 820.40 | Lack of procedures, or not maintained |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |