# FDA 483 - McKeon Products, Inc. - May 07, 2025

Source: https://www.keypedia.com/records/483/mckeon-products-inc/eb0c8ad9-fc30-47da-81c0-8614a5579542

> FDA 483 for McKeon Products, Inc. on May 07, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: McKeon Products, Inc.
- Inspection Date: 2025-05-07
- Product Type: device
- Office Name: Detroit District Office
- Summary: McKeon Products, Inc. in Warren, MI, a medical device establishment, was cited with three observations during an FDA inspection. The inspection revealed significant deficiencies in the firm's quality system, specifically concerning the lack of written Medical Device Reporting (MDR) procedures, inadequate complaint handling processes, and poorly established corrective and preventive action (CAPA) procedures. These issues indicate a systemic failure to maintain proper quality controls and regulatory compliance.

## Related Officers

- [David J. Gasparovich](https://www.keypedia.com/people/david-j-gasparovich/478888db-d4b3-481a-89f5-ee234a160f07)

Company: https://www.keypedia.com/companies/mckeon-products-inc/3dda1a57-ea67-4d29-bddd-cfb8aa3f5d48

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