Overview
- 6 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-09.
At a glance
Inspections
6
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Feb 2026 – 9 Feb 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 13 Oct 2021 – 18 Oct 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 Feb 2016 – 10 Feb 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 28 Oct 2011 | Not recorded | Clean | |
| 5 May 2009 | Not recorded | 483 | On file |
| 6 Aug 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Feb 2026
21 CFR 830.300(a)
Devices subject to device identification GUDID data submission requirements.
Cited by Tyler R Courtney
9 Feb 2026
21 CFR 830.300(a)
Devices subject to device identification GUDID data submission requirements.
Cited by Tyler R Courtney
9 Feb 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
Cited by Tyler R Courtney
Investigators
FDA investigators tied to this site in the record.
Yehualashe A Gessesse3 insp.
Tyler R Courtney1 insp.
Christina L Bigham1 insp.
Jennifer S Ness1 insp.
Susan M Matthias1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 801.40(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 830.300(a) | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 7.3.9 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Collaborative Care Diagnostics, LLC.'s 4 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