FDA 483 - LEVO AG - April 09, 2025

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.