FDA Inspection 1248240 — Dental Health Associates Of Madison, Ltd
The FDA completed an inspection of Dental Health Associates Of Madison, Ltd on Sep 3, 2024 in Fitchburg, WI. 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 3, 2024
- Fiscal Year
- 2024
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Fitchburg, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2269 | 21 CFR 820.20(a) | Quality policy and objectives |
| 2293 | 21 CFR 820.20(d) | Quality plan |
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |