# FDA 483 - Swiss Bionic Solutions GmbH - September 28, 2023

Source: https://www.globalkeysolutions.net/records/483/swiss-bionic-solutions-gmbh/f1568069-da0f-471b-ae9c-95b6802a0cd2

> FDA 483 for Swiss Bionic Solutions GmbH on September 28, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Swiss Bionic Solutions GmbH
- Inspection Date: 2023-09-28
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Swiss Bionic Solutions GmbH in Schindellegi, Switzerland, revealed multiple significant deficiencies in their quality system. The firm failed to establish or adequately implement critical procedures for Medical Device Reporting (MDR), complaint handling, corrective and preventive actions (CAPA), finished device acceptance, and design changes. Additionally, essential documents like the Design History File and Device Master Record were not properly approved.

## Related Officers

- [Esteban Beltran](https://www.globalkeysolutions.net/people/esteban-beltran/9a9bf6b2-ecdf-494c-82f4-5ef5932d629a)

Company: https://www.globalkeysolutions.net/companies/swiss-bionic-solutions-gmbh/2011408d-9132-457d-a27f-ccc09d1571aa

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