FDA Inspection 824133 — Imaging Biometrics LLC
The FDA completed an inspection of Imaging Biometrics LLC on March 22, 2013 in Elm Grove, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 22, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Elm Grove, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 4212 | 21 CFR 806.20(b)(4) | Justification for not reporting |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |