Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-28.
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 |
|---|---|---|---|
| 18 May 2026 – 28 May 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 19 Oct 2017 – 24 Oct 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 31 Oct 2016 – 8 Nov 2016 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
28 May 2026
ISO 13485:2016 Clause 7.3.3
Design and development inputs incomplete or inadequate
Cited by Jamie P Webb
28 May 2026
ISO 13485:2016 Clause 8.2.1
Information gathered in feedback process not used as input into risk management
Cited by Jamie P Webb
28 May 2026
ISO 13485:2016 Clause 8.5.2
Corrective action procedures not documented
Cited by Jamie P Webb
24 Oct 2017
21 CFR 820.30(g)
Design validation- Lack of or inadequate procedures
Cited by James M Simpson
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 820.30(g) | Cited across public-safe Form 483 observations | 8x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.30(c) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 7.3.3 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind DT MedTech, 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