# FDA 483 - Siemens AG/Siemens Healthcare GmbH - January 26, 2023

Source: https://www.keypedia.com/records/483/siemens-agsiemens-healthcare-gmbh/c2f3fdc6-624a-46a4-8e91-ab497c966e6a

> FDA 483 for Siemens AG/Siemens Healthcare GmbH on January 26, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Siemens AG/Siemens Healthcare GmbH
- Inspection Date: 2023-01-26
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Siemens AG/Siemens Healthcare GmbH in Forchheim, Germany, revealed significant deficiencies in their quality system. The firm failed to adequately validate device software, particularly for revisions addressing Class II recalls, and also lacked proper documentation for corrective and preventive action activities. These issues indicate a breakdown in quality control for medical device manufacturing.

## Related Officers

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

Company: https://www.keypedia.com/companies/siemens-agsiemens-healthcare-gmbh/8ae334de-d423-4a84-a8bd-cc3c3224c0af

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