Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-05.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 30 Apr 2026 – 5 May 2026 | Medical Devices & Rad Health | Clean | |
| 8 Dec 2025 – 15 Dec 2025 | Medical Devices & Rad Health | 483 | View 483 → |
| 25 Mar 2024 – 29 Mar 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 9 Dec 2019 – 11 Dec 2019 | Medical Devices & Rad Health | Clean | |
| 15 Mar 2016 – 21 Mar 2016 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
15 Dec 2025
21 CFR 820.30(h)
Design transfer - Lack of or inadequate procedures
Cited by Gamal A Norton
Investigators
FDA investigators tied to this site in the record.
Gamal A Norton3 insp.
Christopher B May2 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(h) | 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 Aptyx Charlotte, LLC's 3 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