FDA 483 - Harmar Mobility, LLC. - July 15, 2022

An FDA inspection of Harmar Mobility, LLC. in Lake Winnebago, MO, a manufacturer of medical devices, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures for design validation, corrective and preventive actions, training, equipment calibration, equipment maintenance, and complaint handling. These findings indicate a systemic lack of adherence to regulatory requirements for medical device manufacturing.