Overview
- 7 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2022-10-18.
At a glance
Inspections
7
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 17 Oct 2022 – 18 Oct 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 21 Nov 2019 | Medical Devices & Rad Health | Clean | |
| 6 Jul 2017 – 7 Jul 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 22 Feb 2012 | Not recorded | 483 | View 483 → |
| 30 Sep 2010 | Not recorded | 483 | View 483 → |
| 22 Apr 2008 | Not recorded | 483 | On file |
| 25 Aug 2005 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
18 Oct 2022
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Christopher S Genther
18 Oct 2022
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Christopher S Genther
18 Oct 2022
21 CFR 820.22
Quality audits - Lack of or inadequate procedures
Cited by Christopher S Genther
18 Oct 2022
21 CFR 820.22
Quality audits - Lack of or inadequate procedures
Cited by Christopher S Genther
18 Oct 2022
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Christopher S Genther
Investigators
FDA investigators tied to this site in the record.
Stephen R Souza2 insp.
Christopher S Genther1 insp.
Paul M Kawamoto1 insp.
Lori J Silverstein1 insp.
Catherine J Laufmann1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 4x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Neuro-Fitness 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