# FDA 483 - Pausch Medical GmbH - February 24, 2023

Source: https://www.globalkeysolutions.net/records/483/pausch-medical-gmbh/2c91298d-bfab-47c5-b38f-79efd6435df4

> FDA 483 for Pausch Medical GmbH on February 24, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pausch Medical GmbH
- Inspection Date: 2023-02-24
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Pausch Medical GmbH in Erlangen, Germany, revealed a significant issue regarding product reporting. The firm failed to submit required product reports and obtain accession numbers for its Uroview FD and Uroview FD II fluoroscopic x-ray medical device systems prior to their introduction into U.S. commerce. This indicates a serious lapse in regulatory compliance for distributed medical devices.

## Related Officers

- [Eric C. Schmitt](https://www.globalkeysolutions.net/people/eric-c-schmitt/f2716c8c-f06e-4519-a1e7-63a3ef6e07fb)

Company: https://www.globalkeysolutions.net/companies/pausch-medical-gmbh/8591914e-f827-4bd6-a345-1ff79eea26d5

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