# FDA 483 - Agiliti Health - Ellis - November 02, 2023

Source: https://www.keypedia.com/records/483/agiliti-health-ellis/f48776ea-410b-4cba-abb3-de559716c428

> FDA 483 for Agiliti Health - Ellis on November 02, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Agiliti Health - Ellis
- Inspection Date: 2023-11-02
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Raye's Inc., a medical device manufacturer in Ellis, KS, was inspected by the FDA and received two observations. The firm failed to adequately establish procedures for finished device acceptance testing and for ensuring purchased products and services conform to specified requirements. These issues indicate deficiencies in their quality system.

## Related Officers

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

Company: https://www.keypedia.com/companies/agiliti-health-ellis/d4867c1e-3961-4deb-bb1b-214e45b40eaa

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