I.T.S. GmbHJanuary 19, 2023

FDA 483 - I.T.S. GmbH - January 19, 2023

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Record Details

An FDA inspection of I.T.S. GmbH in Lasnitzhohe, Austria, from January 16-19, 2023, revealed two significant deficiencies in their quality system. The firm's Medical Device Reporting (MDR) procedure was found to be inadequate, leading to untimely reporting of an event. Additionally, procedures for corrective and preventive actions (CAPA) were not properly established, with issues noted in investigation documentation and information distribution.

Company: I.T.S. GmbH
Inspection Date: January 19, 2023
Product Type: Device
Office: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
Person: Catherine J. Laufmann (Consumer Safety Officer)

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ID · 91502f83-d803-47c5-acac-bffca460b672