Company
United StatesImaging Biometrics LLC, Elm Grove, WI – FDA Inspections
Inspection records and compliance data for Imaging Biometrics LLC in Elm Grove, Wisconsin. 6 FDA inspections on record, 1 Form 483, last inspected March 17, 2025.
Company Profile
This profile covers Imaging Biometrics LLC based in Elm Grove, Wisconsin, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 3
- NAI
- 2
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected September 30, 2009. Last inspected March 17, 2025.
Most cited issue areas
- Records of complaint investigation2 inspections
- Design changes - Lack of or Inadequate Procedures1 inspection
- Design transfer - Lack of or inadequate procedures1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 17, 2025 | Not classified | Medical Devices & Rad Health | 1264124 |
| June 9, 2022 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1171915 |
| October 12, 2018 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1069058 |
| March 22, 2013 | VAI | Medical Devices & Rad Health · Compliance: Devices | 824133 |
| June 24, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 669353 |
| September 30, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 615376 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Imaging Biometrics LLC
FEI Number
3007225492
Address
13416 Watertown Plank Rd Ste 260, Elm Grove, Wisconsin 53122, United States
Country
United States
ID: 8f4a702b-edf7-4323-a70d-2cb451e273fe