# FDA 483 - Steris SA - May 12, 2016

Source: https://www.globalkeysolutions.net/records/483/steris-sa/6bed1957-33d4-4826-a5f4-69bf04b402fc

> FDA 483 for Steris SA on May 12, 2016. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Steris SA
- Inspection Date: 2016-05-12
- Product Type: other
- Office Name: International Compliance Team
- Summary: An FDA inspection of Steris SA, a component sterilizer in Brecey, France, revealed a significant issue where written procedures for component testing were not followed. Specifically, air bubbles were observed during microbiological enumeration of components, a condition explicitly prohibited by the firm's own test procedure. This raises concerns about the accuracy and sensitivity of the test method without supporting data.

## Related Officers

- [Compliance Officer / Investigator](https://www.globalkeysolutions.net/people/erika-v-butler/3e654530-4c29-403d-880e-a5422315c3c0)

Company: https://www.globalkeysolutions.net/companies/steris-sa/c4edba53-1390-4f5a-af17-1f69245f22e0

Office: https://www.globalkeysolutions.net/offices/international-compliance-team/f0ce0d89-bf39-46c6-8c42-28138d161321