FDA 483 - Radiology Information Systems, Inc. - January 17, 2020

Radiology Information Systems, Inc. in Dulles, VA, a medical device manufacturer, was cited for multiple significant quality system deficiencies during an FDA inspection. Key issues include inadequate software validation, insufficient complaint handling and MDR evaluation, and poorly documented corrective and preventive action activities. The firm also demonstrated deficiencies in design change, document control, internal audit procedures, and failed to include UDI/UPC information in its device history records.