FDA 483 - Ra Medical Systems, Inc. - December 11, 2019

An FDA inspection of RA Medical Systems, Inc. in Carlsbad, CA, revealed significant deficiencies in their quality system for manufacturing Class II DABRA Catheters. Observations included a lack of adequate equipment maintenance schedules, inadequately maintained device master records, and failures in document control procedures. These issues indicate a need for comprehensive corrective actions to ensure product quality and regulatory compliance.