Overview
- 6 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-04-06.
At a glance
Inspections
6
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 31 Mar 2026 – 6 Apr 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 13 Mar 2023 – 17 Mar 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 8 May 2018 – 10 May 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Jun 2014 – 11 Jun 2014 | Medical Devices & Rad Health | Clean | |
| 22 Jun 2012 | Not recorded | 483 | View 483 → |
| 11 Feb 2011 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Apr 2026
ISO 13485:2016 Clause 4.1.2
Risk-based approach not applied to QMS processes
Cited by Edward E Lockwood
6 Apr 2026
ISO 13485:2016 Clause 7.3.10
Design and development files not maintained
Cited by Edward E Lockwood
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 | 4x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.30(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(g) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 801.20(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 4.1.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.10 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind National Dentex LLC's 5 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