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LEVO AG, a Swiss manufacturer of Class II standup wheelchairs (LEVO C3, LEVO Combi, LEVO LAE, and LEVO LCEV), was cited for manufacturing adulterated devices that failed to comply with current good manufacturing practice (CGMP) requirements under 21 CFR Part 820. During an April 2025 inspection, the FDA identified failures to establish and maintain an adequate quality system, inadequate medical device report procedures as required by 21 CFR § 803.17, and failure to provide unique device identifier information per 21 CFR § 830.300. The company's response to the FDA's Form 483 observations was received but found insufficient to address the identified compliance gaps.