Medivis, Inc
Form 483 issued March 3, 2026 · New York, New York
- Inspection
- Feb 11 – Mar 3, 2026
- Investigator
- Kwong P. Lee
- Observations
- 2
- Pages
- 4
- FEI number
- 3015536273
In short: On March 3, 2026, FDA issued a Form 483 with 2 observations to Medivis, Inc in New York, New York (FEI 3015536273) after an inspection that ran Feb 11 – Mar 3, 2026. The investigator was Kwong P. Lee. Most observations concern records & documents; the most-cited regulation is 21 CFR 7.3 (definitions).
At a glance
Observations span 1 system, led by records & documents.
Most cited: ISO 13485:2016 Clause 7.3.7 (1×) · 820.181 (1×)
What FDA observed
Preview: the opening words of each observation- 01ISO 13485:2016 Clause 7.3.7
Design and development validation was not…
- 02
A device master record has…
This inspection in context
Kwong P. Lee
12 documents · 2015–2026
Cites 820.30(c) (design controls) more than any other section. Most of their documents are for sites in New York.
The firmMedivis, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.181
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medivis, Inc?
FDA listed 2 observations on this Form 483, mostly about records & documents. The most-cited regulation is 21 CFR 7.3 (definitions). The opening words of each observation are shown on this page.
Who inspected Medivis, Inc?
Kwong P. Lee is named on this Form 483, for the inspection of Feb 11 – Mar 3, 2026. Each investigator has a profile showing what they cite most.
When was Medivis, Inc inspected by FDA?
The inspection ran Feb 11 – Mar 3, 2026, and the Form 483 is dated March 3, 2026.
How do I get the full Form 483 for Medivis, 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.