Atlas

FDA-Inspected Site

Ventana Medical Systems, Inc.

19 FDA inspections are on record for Ventana Medical Systems, Inc. in Tucson, United States.

483· Form 483 issued

Tucson, United States · Last updated August 15, 2026

Overview

  • 19 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2026-02-10.

At a glance

Inspections

19

Form 483s

1

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
2 Feb 2026 – 10 Feb 2026Medical Devices & Rad Health483View 483 →
19 Sep 2022 – 23 Sep 2022Medical Devices & Rad HealthClean
12 Sep 2022 – 15 Sep 2022Medical Devices & Rad HealthClean
27 Jul 2021 – 29 Jul 2021Medical Devices & Rad HealthClean
24 Feb 2020 – 26 Feb 2020Medical Devices & Rad HealthClean
12 Aug 2019 – 14 Aug 2019Medical Devices & Rad HealthClean
10 Jul 2017 – 13 Jul 2017Medical Devices & Rad HealthClean
11 Jul 2016 – 14 Jul 2016Medical Devices & Rad HealthClean
24 Mar 2015 – 27 Mar 2015Medical Devices & Rad HealthClean
17 Jul 2012Not recordedClean
19 Jan 2012Not recordedClean
19 May 2011Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

10 Feb 2026
ISO 13485:2016 Clause 7.5.6

Planned results not consistently met during validation of processes

Cited by Scott D Stevens

10 Feb 2026
ISO 13485:2016 Clause 8.2.2

Correction or corrective action resulting from complaint handling not documented

Cited by Scott D Stevens

Investigators

FDA investigators tied to this site in the record.

Charles L Larson7 insp.
Cheryl D Mccall3 insp.
Scott D Stevens1 insp.
Sherri N Rohlf1 insp.
Katlin N Stubbs1 insp.
Julian C Hanson1 insp.
Janet Pulver1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
ISO 13485:2016 Clause 7.5.6Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.2.2Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Ventana Medical Systems, Inc.'s 1 Form 483

Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat