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

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.