# FDA 483 - I.T.S. GmbH - November 16, 2023

Source: https://www.keypedia.com/records/483/its-gmbh/141b24f7-6de0-4e85-ab49-faa726884b75

> FDA 483 for I.T.S. GmbH on November 16, 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: 2023-11-16
- 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, a medical device manufacturer in Lasnitzhohe, Steiermark, Austria, revealed significant deficiencies in its quality system. Observations included inadequate corrective and preventive action procedures, issues with equipment calibration and identification, and incomplete device history records related to labeling. These findings indicate a need for comprehensive improvements in the firm's quality management processes.

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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