# FDA 483 - Medacta International, SA - November 19, 2024

Source: https://www.keypedia.com/records/483/medacta-international-sa/1eeb130d-a76f-42ba-ba2e-3b2d1667da97

> FDA 483 for Medacta International, SA on November 19, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Medacta International, SA
- Inspection Date: 2024-11-19
- Product Type: device
- Office Name: Office of Medical Device and Radiological Health Operations
- Summary: Medacta International, SA, a medical device manufacturer in Ticino, Switzerland, was inspected by the FDA from November 11-19, 2024. The inspection revealed deficiencies in the firm's complaint handling procedures, specifically regarding immediate documentation and the equal consideration of risk factors for adverse event reporting. This indicates a moderate severity issue related to quality system compliance.

## Related Officers

- [investigator](https://www.keypedia.com/people/wendy-m-stone/715b04f5-3949-4ca6-9bda-26ff611e9354)

Company: https://www.keypedia.com/companies/medacta-international-sa/bab4168c-2be6-426c-b454-a35d77c165ec

Office: https://www.keypedia.com/offices/office-of-medical-device-and-radiological-health-operations/27658190-735a-443e-9087-3534cfe74fd4