Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-02-06.
At a glance
Inspections
6
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Feb 2025 – 6 Feb 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Apr 2022 – 18 Apr 2022 | Medical Devices & Rad Health | Clean | |
| 7 Oct 2019 – 10 Oct 2019 | Medical Devices & Rad Health | 483 | View 483 → |
| 23 May 2017 – 1 Jun 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 7 Aug 2009 | Not recorded | Clean | |
| 6 Mar 2002 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
10 Oct 2019
21 CFR 1002.30(a)(2)
Methods, devices, procedures for testing
Cited by Matthew D Schnittker, Wendy M Stone
10 Oct 2019
21 CFR 1002.30(a)(2)
Methods, devices, procedures for testing
Cited by Matthew D Schnittker, Wendy M Stone
10 Oct 2019
21 CFR 1002.30(a)(2)
Methods, devices, procedures for testing
Cited by Matthew D Schnittker, Wendy M Stone
10 Oct 2019
21 CFR 820.100(a)
Lack of or inadequate procedures
Cited by Matthew D Schnittker, Wendy M Stone
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 1002.30(a)(2) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Caliber Imaging and Diagnostics, Inc.'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