# FDA 483 - Mediso KFT. - April 26, 2023

Source: https://www.keypedia.com/records/483/mediso-kft/bd654aed-a312-4969-8798-e3d00416f28a

> FDA 483 for Mediso KFT. on April 26, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mediso KFT.
- Inspection Date: 2023-04-26
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Mediso KFT. in Budapest, Hungary, a manufacturer, revealed one significant observation regarding their quality system. The firm failed to adequately establish and consistently follow procedures for design changes. This indicates a moderate severity issue related to quality system compliance.

## Related Officers

- [Shannon A. Gregory](https://www.keypedia.com/people/shannon-a-gregory/3e791321-dced-4e1d-89a1-3da91d577961)

Company: https://www.keypedia.com/companies/mediso-kft/bdbf99b2-af2d-4804-8bb5-854ec3b6b8e3

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