FDA 483 - Radiology Information Systems, Inc. - June 18, 2025

Radiology Information Systems, Inc. in Dulles, VA, received a Form 483 with four observations during an FDA inspection. The firm was cited for inadequate procedures regarding design changes and corrective and preventive actions. Additionally, issues were noted with Unique Device Identifier (UDI) labeling for their PowerDR product and the lack of an appointed management representative for quality system oversight.