Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-13.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 10 Mar 2026 – 13 Mar 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 2 May 2022 – 6 May 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 16 Apr 2019 – 19 Apr 2019 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Mar 2026
ISO 13485:2016 Clause 7.1
Records of risk management activities in product realization not maintained
Cited by Jenny L Chisem
Investigators
FDA investigators tied to this site in the record.
Stephen R Souza2 insp.
Jenny L Chisem1 insp.
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 | 7x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.50(a)(1) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.72(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.70(b) | Cited across public-safe Form 483 observations | 3x |
| ISO 13485:2016 Clause 4.2.4 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Diagnostic Consulting Network, 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