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

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.