Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-03-05.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Feb 2025 – 5 Mar 2025 | Medical Devices & Rad Health | Clean | |
| 23 Jan 2015 – 3 Feb 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 Apr 2011 | Not recorded | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Feb 2015
21 CFR 820.30(g)
Design Validation - Risk analysis not performed/inadequate
Cited by Benjamin J Dastoli
4 Apr 2011
21 CFR 820.30(g)
Design validation- Lack of or inadequate procedures
Cited by Laureen M Geniusz
Investigators
FDA investigators tied to this site in the record.
Benjamin J Dastoli2 insp.
Laureen M Geniusz1 insp.
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 | 2x |
| 21 CFR 820.30(f) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Neurowave Systems 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