# FDA 483 - Benchmark Electronics Inc - August 14, 2025

Source: https://www.globalkeysolutions.net/records/483/benchmark-electronics-inc/cabbcfbf-0fd4-402d-9df0-87d707c40327

> FDA 483 for Benchmark Electronics Inc on August 14, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Benchmark Electronics Inc
- Inspection Date: 2025-08-14
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Benchmark Electronics Inc. in Winona, MN, was inspected and received a Form FDA 483 with four observations. The inspection revealed significant deficiencies in process validation, incoming product acceptance procedures, corrective and preventive action systems, and equipment maintenance documentation. These issues indicate a lack of robust quality system controls for manufacturing medical devices.

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/christina-l-bigham/f3da8e26-4a8c-43a8-8070-349fe4500289)

Company: https://www.globalkeysolutions.net/companies/benchmark-electronics-inc/b8450d5d-bd27-471e-bebd-fdb9c747624e

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d