FDA 483 - Corindus, Inc. - January 25, 2024

Corindus, Inc. in Auburndale, MA, a manufacturer of the CorPath GRX System and Cassette, was inspected by the FDA. The inspection revealed significant deficiencies in their quality system, specifically concerning corrective and preventive actions (CAPA), complaint handling, and environmental controls for manufacturing. These issues indicate a lack of adherence to established procedures and proper documentation practices.