Medacta International, SANovember 19, 2024

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

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Record Details

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.

Company: Medacta International, SA
Inspection Date: November 19, 2024
Product Type: Device
Office: Office of Medical Device and Radiological Health Operations
Person: Wendy M. Stone (investigator)

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ID · 1eeb130d-a76f-42ba-ba2e-3b2d1667da97