IPAX, Incorporated
Form 483 issued February 5, 2026 · Englewood, Colorado
- Inspection
- Feb 3 – Feb 5, 2026
- Investigator
- Matthew M. Vernon
- Observations
- 1
- Pages
- 4
- FEI number
- 1720734
In short: On February 5, 2026, FDA issued a Form 483 with 1 observation to IPAX, Incorporated in Englewood, Colorado (FEI 1720734) after an inspection that ran Feb 3 – Feb 5, 2026. The investigator was Matthew M. Vernon. The most-cited regulation is 21 CFR 7.1 (scope).
What FDA observed
Preview: the opening words of each observation- 01ISO 13485:2016 Clause 7.1
One or more processes for risk management in product realization have…
This inspection in context
Matthew M. Vernon
6 documents · 2020–2026
Cites 820.20(b)(3) (management responsibility) more than any other section. Most of their documents are for sites in Colorado.
The firmIPAX, Incorporated history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at IPAX, Incorporated?
FDA listed 1 observation on this Form 483. The most-cited regulation is 21 CFR 7.1 (scope). The opening words of each observation are shown on this page.
Who inspected IPAX, Incorporated?
Matthew M. Vernon is named on this Form 483, for the inspection of Feb 3 – Feb 5, 2026. Each investigator has a profile showing what they cite most.
When was IPAX, Incorporated inspected by FDA?
The inspection ran Feb 3 – Feb 5, 2026, and the Form 483 is dated February 5, 2026.
How do I get the full Form 483 for IPAX, Incorporated?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.