# FDA 483 - LEVO AG - April 09, 2025

Source: https://www.globalkeysolutions.net/records/483/levo-ag/a2e40a26-9288-4666-84ae-74fe37b8a7f6

> FDA 483 for LEVO AG on April 09, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LEVO AG
- Inspection Date: 2025-04-09
- Product Type: device
- Office Name: Office of Inspections and Investigations
- Summary: LEVO AG, a medical device manufacturer in Wohlen, Switzerland, was cited for significant deficiencies across its quality system during an FDA inspection. The firm failed to establish a comprehensive quality system, complaint handling procedures, and Medical Device Reporting procedures for its Class II Standup Wheelchairs. Additionally, the company did not submit required device information to the GUDID and its personnel lacked adequate knowledge of relevant FDA regulations.

## Related Officers

- [Felix J. Marrero](https://www.globalkeysolutions.net/people/felix-j-marrero/fe3bf64e-987b-40d9-8a17-754d58e13433)

Company: https://www.globalkeysolutions.net/companies/levo-ag/1dd4c92b-b75a-4a3a-91c1-712cc935ceab

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8