Amigo Mobility International, Inc.
Form 483 issued February 5, 2026
- Inspection
- Feb 2 – Feb 5, 2026
- Investigator
- David Gasparovich
- Observations
- 6
- Pages
- 7
- FEI number
- 1821729
In short: On February 5, 2026, FDA issued a Form 483 with 6 observations to Amigo Mobility International, Inc. (FEI 1821729) after an inspection that ran Feb 2 – Feb 5, 2026. The investigator was David Gasparovich. Most observations concern cAPA and management controls.
At a glance
CAPA and management controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
One or more processes for risk management in product realization have…
- 02
Corrective action procedures defining the requirements for determining the causes of nonconformities and reviewing the effectiveness…
- 03
Nonconforming product was not adequately evaluated to determine the need for an investigation and notification of…
- 04
Process(es) for establishing competence, providing needed training and ensuring personnel awareness have…
This inspection in context
David Gasparovich
8 documents · 2015–2026
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Illinois.
The firmAmigo Mobility International, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Amigo Mobility International, Inc.?
FDA listed 6 observations on this Form 483, mostly about cAPA, management controls and design controls. The opening words of each observation are shown on this page.
Who inspected Amigo Mobility International, Inc.?
David Gasparovich is named on this Form 483, for the inspection of Feb 2 – Feb 5, 2026. Each investigator has a profile showing what they cite most.
When was Amigo Mobility International, Inc. inspected by FDA?
The inspection ran Feb 2 – Feb 5, 2026, and the Form 483 is dated February 5, 2026.
How do I get the full Form 483 for Amigo Mobility International, Inc.?
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.