FDA 483 - Coapt LLC - November 02, 2022

Coapt LLC in Chicago, IL, was inspected from October 28 to November 2, 2022, and received a Form FDA 483 with three observations. The inspection revealed significant deficiencies including the failure to submit a Medical Device Report for a device malfunction causing patient burns, lack of justification for not reporting a correction action to the FDA, and inadequate maintenance of document change records for their hazard matrix. These issues indicate a need for improved quality system controls.