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Onkos Surgical, Inc. was cited for manufacturing the ELEOS Limb Salvage System (used in hip and knee replacement surgery) in violation of FDA's Quality System Regulation (21 CFR Part 820), with the company's devices deemed adulterated due to non-conforming manufacturing, storage, and control procedures. During a two-month inspection from February through April 2025, FDA investigators identified failures in the company's supplier control procedures, specifically noting the firm's inability to ensure that purchased products and services met specified quality requirements. The company submitted a response in May 2025 addressing the initial Form FDA 483 observations, though the violations were serious enough to warrant formal warning letter enforcement rather than closure.