FDA Inspection 1072029 — Archtek Dental, LLC
The FDA completed an inspection of Archtek Dental, LLC on October 25, 2018 in Carmel, IN. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- October 25, 2018
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Carmel, IN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |