# FDA 483 - Mario Campone - November 07, 2025

Source: https://www.globalkeysolutions.net/records/483/mario-campone/86e2864f-0daa-42e4-99cd-ecf2cf08e649

> FDA 483 for Mario Campone on November 07, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mario Campone
- Inspection Date: 2025-11-07
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of Mario Campone, MD, PHD, a clinical investigator in Saint Herblain Cedex, France, revealed significant issues with the accuracy of case histories for a Phase 3 clinical trial. Specifically, the firm failed to report all non-serious adverse events and concomitant medications for subjects randomized into the study. This indicates deficiencies in data integrity and reporting practices during the clinical investigation.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/tawny-l-colling/4ce51467-468c-4271-a98d-4b13c15c0812)

Company: https://www.globalkeysolutions.net/companies/mario-campone/989af96d-907d-4f05-b911-f3f557ec17ef

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