FDA 483 - Plus EV Holdings, Inc. - December 12, 2024

An FDA inspection of Plus EV Holdings, Inc. in North Kansas City, MO, from December 11-12, 2024, revealed a significant lack of established and documented design controls for Class II medical devices. The firm failed to perform and document essential design control activities, including design inputs, reviews, verification, and validation, for distributed vaginal dilators and kegel exercise systems. This indicates a serious deficiency in the firm's quality system regarding product development and release.