# Midwest-Tek, Inc. – FDA 483, Apr 1, 2026

Source: https://www.keypedia.com/records/483/midwest-tek-inc/db4b42d0-af89-483d-ad5d-60eccfc07563

> FDA 483 for Midwest-Tek, Inc. on April 01, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Midwest-Tek, Inc.
- Inspection Date: 2026-04-01
- Product Type: device
- Office Name: Detroit District Office
- Summary: An FDA inspection of Midwest-Tek, Inc., a manufacturer in New Albany, IN, revealed significant deficiencies in their quality system. The firm failed to adequately validate production processes, manage design changes, implement production controls, maintain records for nonconforming products, and document record control procedures. These issues indicate a lack of robust quality management practices across several critical areas.

## Related Officers

- [Shannon A. Gregory](https://www.keypedia.com/people/shannon-a-gregory/3e791321-dced-4e1d-89a1-3da91d577961)

Company: https://www.keypedia.com/companies/midwest-tek-inc/14df809a-c9fe-41fb-86cb-d51cb85a531d

Office: https://www.keypedia.com/offices/detroit-district-office/b09a1815-a000-40c0-bb44-5432ce87ed03