FDA Inspection 1222844 — Advantage Dental Products, Inc.
The FDA completed an inspection of Advantage Dental Products, Inc. on Nov 16, 2023 in Clarkston, MI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 16, 2023
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Clarkston, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 14718 | 21 CFR 820.30(g) | Design validation - Risk analysis |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3104 | 21 CFR 820.30(j) | Design history file |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 479 | 21 CFR 820.50 | Purchasing controls, Lack of or inadequate procedures |