# FDA 483 - Ionisos S.A.S. - April 02, 2024

Source: https://www.globalkeysolutions.net/records/483/ionisos-sas/8569c325-54e3-4704-bfb5-04a0107733f5

> FDA 483 for Ionisos S.A.S. on April 02, 2024. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ionisos S.A.S.
- Inspection Date: 2024-04-02
- Product Type: other
- Office Name: International Compliance Team
- Summary: IONISOS, a contract sterilizer in Sable-sur-Sarthe, France, was inspected by the FDA from April 2 to May 2024. The inspection revealed deficiencies primarily concerning process validation activities and supplier qualification. Specifically, the firm failed to adequately validate processes and qualify suppliers for critical services.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/stephen-d-eich/a932e816-cbe3-4f1c-84e7-8a81cc8b529e)

Company: https://www.globalkeysolutions.net/companies/ionisos-sas/def8aeba-584d-46ce-b3b6-3d7ddf0a5e50

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