483
Radiology Information Systems, Inc.Radiology Information Systems, Inc. – FDA 483, Jun 18, 2025
Record Details
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.
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