Overview
- 5 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-13.
At a glance
Inspections
5
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 9 Feb 2026 – 13 Feb 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 Apr 2022 – 14 Apr 2022 | Medical Devices & Rad Health | Clean | |
| 19 Jun 2017 – 23 Jun 2017 | Medical Devices & Rad Health | 483 | View 483 → |
| 13 Feb 2012 | Not recorded | 483 | On file |
| 30 Dec 2008 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
13 Feb 2026
ISO 13485:2016 Clause 4.1.2
Risk-based approach not applied to QMS processes
Cited by Javelle P Spann
23 Jun 2017
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by Mary A Millner
23 Jun 2017
21 CFR 820.90(a)
Nonconforming product, Lack of or inadequate procedures
Cited by Mary A Millner
Investigators
FDA investigators tied to this site in the record.
Javelle P Spann1 insp.
Nikki S Bryant1 insp.
Mary A Millner1 insp.
Erica M Katherine1 insp.
Thomas O Morgan1 insp.
Christophe L Boulmay1 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 | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 4.1.2 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Onyx Medical, 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