Overview
- 6 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-06.
At a glance
Inspections
6
Form 483s
3
EIRs
1
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 6 May 2026 | Medical Devices & Rad Health | Clean | |
| 9 Jan 2023 – 11 Jan 2023 | Medical Devices & Rad Health | Clean | |
| 29 Nov 2016 – 2 Dec 2016 | Medical Devices & Rad Health | Clean | |
| 3 Jun 2014 – 9 Jun 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 25 Jun 2013 – 2 Jul 2013 | Medical Devices & Rad Health | 483 | View 483 → |
| 20 Nov 2012 | Not recorded | WL | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
9 Jun 2014
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by Andrew Saunders
9 Jun 2014
21 CFR 820.90(b)(1)
Procedures for product review,disposition lack of/inadequate
Cited by Andrew Saunders
Investigators
FDA investigators tied to this site in the record.
Lacey J Chessor2 insp.
Jamie P Webb1 insp.
Nikki S Bryant1 insp.
Charvais S Hill1 insp.
Mary A Millner1 insp.
Andrew Saunders1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.181 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.184 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.22 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.25(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(j) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.20(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50(b) | 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(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.80(e) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(1) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Aionex, Inc.'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