# FDA 483 - Sterigenics Belgium (Fleurus) S.A. - November 07, 2024

Source: https://www.globalkeysolutions.net/records/483/sterigenics-belgium-fleurus-sa/2f46a5cb-bca3-41da-a40c-a7736870ee6a

> FDA 483 for Sterigenics Belgium (Fleurus) S.A. on November 07, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sterigenics Belgium (Fleurus) S.A.
- Inspection Date: 2024-11-07
- Product Type: device
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Sterigenics Belgium (Fleurus) S.A., a contract sterilizer in Fleurus, Belgium, from November 4-7, 2024, revealed significant deficiencies in the firm's corrective and preventive action (CAPA) procedures. The firm failed to adequately establish and follow CAPA procedures, including addressing root causes, ensuring proper follow-up, and documenting corrective actions for identified issues. This indicates a moderate level of non-compliance with quality system requirements.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/sterigenics-belgium-fleurus-sa/e60eb6dd-b598-4c67-acb8-e7ed75db365f

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