FDA 483 - Electroskip, Llc - June 07, 2022

Electroskip, Llc, a medical device manufacturer in Buffalo, NY, was inspected by the FDA from June 1-7, 2022. The inspection revealed significant deficiencies across multiple quality system areas, particularly concerning design controls, corrective and preventive actions, complaint handling, and document control. The firm lacked adequately established procedures and documentation for critical processes related to its eskipitrainer device.