Visionary Medical Supplies Inc
Form 483 issued February 25, 2026 · Madison, Wisconsin
- Inspection
- Feb 23 – Feb 25, 2026
- Investigator
- Shawn Choi
- Observations
- 1
- Pages
- 4
- FEI number
- 3004161528
In short: On February 25, 2026, FDA issued a Form 483 with 1 observation to Visionary Medical Supplies Inc in Madison, Wisconsin (FEI 3004161528) after an inspection that ran Feb 23 – Feb 25, 2026. The investigator was Shawn Choi. The most-cited regulation is 21 CFR 4.1 (what is the scope of this subpart?).
What FDA observed
Preview: the opening words of each observation- 01ISO 13485:2016 Clause 4.1.1
The quality management system effectiveness was not maintained in accordance…
This inspection in context
Shawn Choi
4 documents · 2024–2026
Cites 820.20(a) (management responsibility) more than any other section. Most of their documents are for sites in Wisconsin.
The firmVisionary Medical Supplies Inc history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at Visionary Medical Supplies Inc?
FDA listed 1 observation on this Form 483. The most-cited regulation is 21 CFR 4.1 (what is the scope of this subpart?). The opening words of each observation are shown on this page.
Who inspected Visionary Medical Supplies Inc?
Shawn Choi is named on this Form 483, for the inspection of Feb 23 – Feb 25, 2026. Each investigator has a profile showing what they cite most.
When was Visionary Medical Supplies Inc inspected by FDA?
The inspection ran Feb 23 – Feb 25, 2026, and the Form 483 is dated February 25, 2026.
How do I get the full Form 483 for Visionary Medical Supplies 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.