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

Source: https://www.keypedia.com/records/483/its-gmbh/91502f83-d803-47c5-acac-bffca460b672

> FDA 483 for I.T.S. GmbH on January 19, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: I.T.S. GmbH
- Inspection Date: 2023-01-19
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: 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.

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## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/catherine-j-laufmann/920b7656-2847-408d-ba15-3989283d8c94)

Company: https://www.keypedia.com/companies/its-gmbh/222e9947-d8bf-4009-9811-979b8bd114c6

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd