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# QS, MDR, UDI Issues in Levo AG Inspection
- URL: https://www.fdaweb.com/qs-mdr-udi-issues-in-levo-ag-inspection/
- Published: 2025-10-21T12:00:00.000Z
- Updated: 2026-09-14T15:24:36.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160073

A 4/7-4/9 FDA inspection at Levo AG in Wohlen, Switzerland, found multiple violations in the firm’s manufacturing of several models of Class 2 stand-up wheelchairs. A just-released 7/18 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/levo-ag-717287-07182025?ref=fdaweb.com) says the specific violations were:

- failure to establish and maintain a quality system that is appropriate for the specific medical devices designed and manufactured;
- failure to adequately develop, maintain, and implement written Medical Device Reporting procedures; and
- failure to ensure that the labeler of a device provides the information required by the subpart for each version or model required to bear a unique device identifier.

The letter says the adequacy of the firm’s responses to the inspection observations cannot be determined at this time. FDA says that due to the seriousness of the violations, it is taking steps to refuse entry of Levo devices into the U.S. until the violations are addressed.

Levo was told to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation of the actions and a schedule for completing the corrections.