483
Max Mobility LLCFDA 483 - Max Mobility LLC - April 16, 2026
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An FDA inspection of Max Mobility LLC in Lebanon, TN, a specification developer, revealed significant deficiencies in their procedures for controlling design and development changes. The firm failed to adequately evaluate changes affecting the safety and function of their SmartDrive Power Assist device, leading to a Class I recall for a SpeedControl dial design change and inadequate verification of new mobile and smartwatch applications.
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