# FDA 483 - Midwest Products and Engineering Inc - August 29, 2025

Source: https://www.globalkeysolutions.net/records/483/midwest-products-and-engineering-inc/caf3d268-bfdd-43b8-9475-15944871b4ab

> FDA 483 for Midwest Products and Engineering Inc on August 29, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Midwest Products and Engineering Inc
- Inspection Date: 2025-08-29
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: An FDA inspection of Midwest Products and Engineering, Inc. in Milwaukee, WI, a medical device contract manufacturer, revealed two significant observations. The firm's corrective and preventive action (CAPA) procedures were found to be inadequately established, with several CAPA records lacking sufficient investigations. Additionally, procedures for ensuring purchased products and services conform to requirements were not adequately implemented, as evidenced by suppliers in "conditional" status without required mitigation plans or audits.

## Related Officers

- [Chad E. Schmear](https://www.globalkeysolutions.net/people/chad-e-schmear/275a4c57-d288-46f9-8257-64fcd96159ce)

Company: https://www.globalkeysolutions.net/companies/midwest-products-and-engineering-inc/8a6fa11e-fc45-4e1e-a6bd-1f524752d635

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