Overview
- 8 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-05.
At a glance
Inspections
8
Form 483s
4
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 3 Feb 2026 – 5 Feb 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 3 Oct 2018 – 11 Oct 2018 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Feb 2016 – 2 Mar 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 1 Apr 2014 – 9 Apr 2014 | Medical Devices & Rad Health | 483 | View 483 → |
| 7 Aug 2007 | Not recorded | Clean | |
| 28 Oct 2005 | Not recorded | Clean | |
| 2 Apr 2003 | Not recorded | Clean | |
| 30 Oct 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
5 Feb 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
Cited by Matthew M Vernon
5 Feb 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
Cited by Matthew M Vernon
Investigators
FDA investigators tied to this site in the record.
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 | 6x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 3x |
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind IPAX, Incorporated's 4 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