FDA Inspection 805861 — Dane Technologies
The FDA completed an inspection of Dane Technologies on October 17, 2012 in Maple Grove, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 17, 2012
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Maple Grove, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3409 | 21 CFR 820.200(d) | Service reports |
| 3669 | 21 CFR 820.20(c) | Management review - defined interval, sufficient frequency |
| 419 | 21 CFR 820.20(b) | Lack of or inadequate organizational structure |