FDA Inspection 1200171 — National Dentex LLC
The FDA completed an inspection of National Dentex LLC on March 17, 2023 in Fenton, MO. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 17, 2023
- Fiscal Year
- 2023
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Fenton, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |