Overview
- 6 FDA inspections are on record.
- 6 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-03.
At a glance
Inspections
6
Form 483s
6
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 27 Feb 2026 – 3 Mar 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 Apr 2022 – 11 Apr 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 17 Jul 2017 – 19 Jul 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 7 Apr 2014 – 10 Apr 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 5 Aug 2010 | Not recorded | 483 | View 483 → |
| 9 Jan 2008 | Not recorded | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Mar 2026
ISO 13485:2016 Clause 6.2
Process(es) for personnel competence, training and awareness not documented
Cited by Matthew T Sanchez
3 Mar 2026
ISO 13485:2016 Clause 6.2
Process(es) for personnel competence, training and awareness not documented
Cited by Matthew T Sanchez
3 Mar 2026
ISO 13485:2016 Clause 7.3.7
Design and development validation not performed as planned
Cited by Matthew T Sanchez
Investigators
FDA investigators tied to this site in the record.
Matthew T Sanchez1 insp.
Dawn M Braswell1 insp.
Karen M Rodriguez1 insp.
Melanie W Pishnery1 insp.
Melanie G Warzala1 insp.
Jason P Aun1 insp.
Leo J Lagrotte1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 7x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 6x |
| 21 CFR 820.20(c) | 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 | 6x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.30(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 3x |
| ISO 13485:2016 Clause 4.2.4 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 6.2 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 7.3.7 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 8.2.4 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.70(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(d) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Applied Neuroscience, Inc.'s 6 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