# FDA 483 - Noras MRT Products GmbH - May 17, 2018

Source: https://www.globalkeysolutions.net/records/483/noras-mrt-products-gmbh/9acc2076-4a71-42ea-ba29-8458f4f4187d

> FDA 483 for Noras MRT Products GmbH on May 17, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Noras MRT Products GmbH
- Inspection Date: 2018-05-17
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Noras MRT Products GmbH in Hochberg, Germany, revealed four significant quality system deficiencies. The firm failed to adequately review and revalidate processes after changes, maintain device master records, conduct proper risk analysis, and ensure device history records align with master records. These issues indicate a lack of robust quality control in medical device manufacturing.

## Related Officers

- [Andrew J. Garufi](https://www.globalkeysolutions.net/people/andrew-j-garufi/567f6aaa-f6f2-45a3-9a58-80b33f3ad021)

Company: https://www.globalkeysolutions.net/companies/noras-mrt-products-gmbh/672e250e-888b-4645-b745-ce166d7d4c54

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