# FDA 483 - Ventana Medical Systems, Inc. - February 10, 2026

Source: https://www.keypedia.com/records/483/ventana-medical-systems-inc/500fcc7b-00d4-42cc-8931-dd8ab6034d42

> FDA 483 for Ventana Medical Systems, Inc. on February 10, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ventana Medical Systems, Inc.
- Inspection Date: 2026-02-10
- Product Type: device
- Office Name: FDA District Office — Denver, Colorado
- Summary: Ventana Medical Systems, Inc. in Oro Valley, AZ, a medical device manufacturer, received two observations during an FDA inspection. The firm was cited for inadequate documentation of corrective actions within their complaint handling process and for insufficient process validation for their Ventana PTEN Assay. These findings indicate deficiencies in their quality management system.

## Related Officers

- [Scott D. Stevens](https://www.keypedia.com/people/scott-d-stevens/8d5a611a-4f0c-4e3a-9da7-3c872b08f91e)

Company: https://www.keypedia.com/companies/ventana-medical-systems-inc/fbee7b78-8ed8-4956-853d-aae637e77eab

Office: https://www.keypedia.com/offices/fda-district-office-denver-colorado/1670d160-cbfd-48fd-b9c1-fbba4631fcb0