Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-03-17.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Mar 2025 | Medical Devices & Rad Health | Clean | |
| 8 Jun 2022 – 9 Jun 2022 | Medical Devices & Rad Health | Clean | |
| 3 Oct 2018 – 12 Oct 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 19 Mar 2013 – 22 Mar 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 24 Jun 2010 | Not recorded | Clean | |
| 30 Sep 2009 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
12 Oct 2018
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Michelle J Glembin
Investigators
FDA investigators tied to this site in the record.
Shuana H Xiong1 insp.
Chad E Schmear1 insp.
Jennifer S Ness1 insp.
Michelle J Glembin1 insp.
Melissa J Holz1 insp.
Richard J Tucker1 insp.
Sandra A Hughes1 insp.
Aaron L Dunbar1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.17(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 806.20(b)(4) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(h) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Imaging Biometrics LLC's 3 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat