Overview
- 7 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2023-10-26.
At a glance
Inspections
7
Form 483s
4
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 24 Oct 2023 – 26 Oct 2023 | Medical Devices & Rad Health | Clean | |
| 3 May 2022 – 5 May 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 13 Nov 2017 – 15 Nov 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 2 Dec 2013 – 4 Dec 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 31 Aug 2010 | Not recorded | 483 | View 483 → |
| 2 Mar 2007 | Not recorded | Clean | |
| 16 Sep 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Laiza V Garcia1 insp.
Nydia E Colon1 insp.
Lisa A Warner1 insp.
Lindsay R Hatch1 insp.
Richard K Vogel1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(c) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(g) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Neurotronics LLC.'s 4 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