483
Medacta International, SAMedacta International, SA – FDA 483, Nov 19, 2024
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.
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ID · 1eeb130d-a76f-42ba-ba2e-3b2d1667da97
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