# FDA 483 - Steris - May 24, 2022

Source: https://www.keypedia.com/records/483/steris/1ccc72b3-6253-483d-81bc-08c11bf16ce4

> FDA 483 for Steris on May 24, 2022. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Steris
- Inspection Date: 2022-05-24
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Zutron Medical LLC in Lenexa, KS, was inspected by the FDA from May 20-24, 2022. The inspection resulted in one observation concerning the firm's failure to adequately establish procedures for controlling and documenting non-conforming medical products. This indicates a lapse in their quality system regarding product control and record-keeping.

## Related Officers

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

Company: https://www.keypedia.com/companies/steris/6e20da70-37c0-4dc7-8e0c-9a2c5e589637

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