# Ionisos – FDA 483, Sep 12, 2024

Source: https://www.keypedia.com/records/483/ionisos/fd5f263b-cf97-4a1f-89ca-21573c554708

> FDA 483 for Ionisos on September 12, 2024. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ionisos
- Inspection Date: 2024-09-12
- Product Type: other
- Office Name: Office of Inspections and Investigations
- Summary: Ioniscs, a contract gamma sterilizer in Pouzauges, France, received four observations during an FDA inspection. The inspection revealed significant deficiencies in the firm's quality system, including inadequate procedures for change control, software validation, deviation management, and corrective and preventive actions. These issues led to the implementation of unvalidated software and non-compliant product treatments.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/maryam-tabatabaie/b792042d-e296-446d-90a9-d30c8f635506)

Company: https://www.keypedia.com/companies/ionisos/1c6a384e-c85d-4aaa-aa35-b42bb9f1e9c2

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