Overview
- 2 public-safe observations are available for this inspection.
- 1 structured CFR citation is represented.
- 1 investigator is tied to this Form 483.
Inspectional observations
Each observation cites the regulation FDA found the firm out of compliance with.
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
Inspected site
IIIPAX, IncorporatedEnglewood, United States
Inspection team
Cited regulations
CFR citations associated with this Form 483.
| Citation | What it covers | Cited |
|---|---|---|
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 2x |
Source document
PDF
PDF available
Form 483 source document
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Full 483 report
Get the verbatim text of all 2 observations
The source PDF, so your team sees exactly what was cited and how it was answered.
- The site's full inspection history around this Form 483
- Whether these citations escalated to a warning letter
- The investigators involved and the citations they repeat elsewhere