# FDA 483 - Steris S.p.A. - February 26, 2026

Source: https://www.keypedia.com/records/483/steris-spa/b762e0ba-a8da-48b3-a5b2-3b34c0eb4a9d

> FDA 483 for Steris S.p.A. on February 26, 2026. Product: other. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Steris S.p.A.
- Inspection Date: 2026-02-26
- Product Type: other
- Office Name: Office of Inspections and Investigations
- Summary: Steris S.p.A., a contract sterilizer in Seriate, Italy, was cited for an inadequate risk-based approach to its quality management system. The firm failed to properly evaluate and assess risks associated with dosimeter conditioning wait-times and potential manufacturing defects in its Process Failure Mode Effects Analysis (pFMEA). This indicates a significant deficiency in ensuring the reliability and control of their sterilization processes.

## Related Officers

- [Scott D. Stevens](https://www.keypedia.com/people/scott-d-stevens/8d5a611a-4f0c-4e3a-9da7-3c872b08f91e)

Company: https://www.keypedia.com/companies/steris-spa/0411b122-8818-4f0c-82da-9d906deb7ebd

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8