FDA 483 - Wello, Inc. - June 21, 2023

Wello, Inc., a medical device manufacturer in Addison, TX, was inspected by the FDA and received a Form 483 with seven observations, including repeat findings from 2019. The inspection revealed significant deficiencies in design verification documentation, supplier evaluation, CAPA processes, incoming product acceptance, service reporting, rework documentation, and device history records. These issues indicate a systemic lack of adherence to quality system requirements for medical device manufacturing.