FDA 483 - Dragon Heart Medical Inc. - July 02, 2021

Dragon Heart Medical Inc., a medical device specification developer and initial importer in Elmhurst, IL, was cited for four significant quality system deficiencies during an FDA inspection. These issues include inadequate design history files, poorly maintained device master records, insufficient supplier controls, and poorly documented corrective and preventive actions, with two of the observations being repeat findings. The findings indicate systemic problems in maintaining compliant quality system records and procedures.