FDA WARNING_LETTER - LEVO AG - April 09, 2025

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to LEVO AG, a Swiss manufacturer of Class II Standup Wheelchairs, following an inspection conducted from April 7-9, 2025. The inspection revealed that LEVO AG"s medical devices are considered adulterated because their manufacturing processes and controls do not conform to the FDA"s Quality System regulation (21 CFR Part 820). The primary issue identified was a systemic failure to establish and maintain an appropriate quality system, with missing documentation across nearly all essential areas. These included management responsibility, quality audits, personnel training, design controls, document controls, purchasing controls, production and process controls, acceptance activities, nonconforming product procedures, corrective and preventive actions, labeling, packaging, and comprehensive record-keeping, including complaint files. Additionally, the firm failed to adequately establish and maintain medical device report procedures (21 CFR § 803.17) and did not provide required unique device identifier information for its products (21 CFR § 830.300).

While LEVO AG provided corrective action plans, including a temporary suspension of device exports to the U.S., the FDA determined the adequacy of these responses could not be confirmed without further evidence. To achieve compliance, the FDA requires LEVO AG to submit comprehensive documentation addressing all requirements of 21 CFR Part 820 and provide training records demonstrating adherence to these Quality System requirements.