# FDA 483 - Varex Imaging Corporation - August 25, 2025

Source: https://www.globalkeysolutions.net/records/483/varex-imaging-corporation/9a86dbf6-1387-48de-ad64-921711164b81

> FDA 483 for Varex Imaging Corporation on August 25, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Varex Imaging Corporation
- Inspection Date: 2025-08-25
- Product Type: device
- Office Name: Denver District Office
- Summary: Varex Imaging Corporation, a medical device manufacturer in Salt Lake City, UT, was inspected by the FDA and received a Form 483 with six observations. The inspection revealed significant deficiencies in process control, incoming inspection procedures, record retention, and corrective and preventive actions. These issues indicate a lack of adequate quality system controls.

## Related Officers

- [James R. Montero](https://www.globalkeysolutions.net/people/james-r-montero/ce2d19fd-25b7-423e-9132-5d6f582380d2)

Company: https://www.globalkeysolutions.net/companies/varex-imaging-corporation/06d296c0-92cb-475b-b243-57fcd6c1fef7

Office: https://www.globalkeysolutions.net/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face