# FDA 483 - Medical Solutions International, Inc. - April 15, 2024

Source: https://www.keypedia.com/records/483/medical-solutions-international-inc/9556220c-0b6f-4bf7-a372-1ffd4062e9a5

> FDA 483 for Medical Solutions International, Inc. on April 15, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medical Solutions International, Inc.
- Inspection Date: 2024-04-15
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Medical Solutions International, Inc. in Merriam, KS, a manufacturer of Class II medical devices, was cited for significant deficiencies in its design control procedures. The inspection revealed inadequate establishment of procedures for design validation, incomplete risk analysis, and insufficient procedures for both design verification and design change. All four observations were noted as repeat findings from a previous FDA inspection.

## Related Officers

- [Eric C. Fox](https://www.keypedia.com/people/eric-c-fox/218af117-1551-476f-80ba-172e2cd6baee)

Company: https://www.keypedia.com/companies/medical-solutions-international-inc/91fc759a-739f-4e4f-a4e3-e8b428939d76

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8