Mediso KFT.April 26, 2023

FDA 483 - Mediso KFT. - April 26, 2023

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Record Details

An FDA inspection of Mediso KFT. in Budapest, Hungary, a manufacturer, revealed one significant observation regarding their quality system. The firm failed to adequately establish and consistently follow procedures for design changes. This indicates a moderate severity issue related to quality system compliance.

Company: Mediso KFT.
Inspection Date: April 26, 2023
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Shannon A. Gregory

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ID · bd654aed-a312-4969-8798-e3d00416f28a