Ventana Medical Systems, Inc.
Form 483 issued February 10, 2026 · Oro Valley, Arizona
- Inspection
- Feb 2 – Feb 10, 2026
- Investigator
- Scott D. Stevens
- Observations
- 2
- Pages
- 4
- FEI number
- 1000125183
In short: On February 10, 2026, FDA issued a Form 483 with 2 observations to Ventana Medical Systems, Inc. in Oro Valley, Arizona (FEI 1000125183) after an inspection that ran Feb 2 – Feb 10, 2026. The investigator was Scott D. Stevens.
What FDA observed
Preview: the opening words of each observation- 01
Correction or corrective action resulting from the complaint handling process…
- 02
Validation of processes for production and service provision did not adequately demonstrate the ability of the…
This inspection in context
Scott D. Stevens
3 documents · 2024–2026
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Arizona.
The firmVentana Medical Systems, Inc. history
The site's inspection history, in date order.
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Questions about this 483
What did FDA find at Ventana Medical Systems, Inc.?
FDA listed 2 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Ventana Medical Systems, Inc.?
Scott D. Stevens is named on this Form 483, for the inspection of Feb 2 – Feb 10, 2026. Each investigator has a profile showing what they cite most.
When was Ventana Medical Systems, Inc. inspected by FDA?
The inspection ran Feb 2 – Feb 10, 2026, and the Form 483 is dated February 10, 2026.
How do I get the full Form 483 for Ventana Medical Systems, 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.