FDA Inspection 1069058 — Imaging Biometrics LLC
The FDA completed an inspection of Imaging Biometrics LLC on October 12, 2018 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 12, 2018
- Fiscal Year
- 2019
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Elm Grove, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |