Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-27.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 5 May 2026 – 27 May 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Nov 2017 – 15 Nov 2017 | Medical Devices & Rad Health | Clean | |
| 6 May 2015 – 7 May 2015 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
27 May 2026
ISO 13485:2016 Clause 7.1
Records of risk management activities in product realization not maintained
Cited by Monica L Gutierrez
27 May 2026
ISO 13485:2016 Clause 7.3.6
Design and development verification not performed
Cited by Monica L Gutierrez
27 May 2026
ISO 13485:2016 Clause 8.2.2
Lack of documented justification for not investigating complaint(s)
Cited by Monica L Gutierrez
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 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.184(e) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.6 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.2 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind NeuroMetrix, Inc.'s 2 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