483
Radiology Information Systems, Inc.FDA 483 - Radiology Information Systems, Inc. - June 18, 2025
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
- Person
Open in Dashboard
ID · 7da5326c-df4a-42d8-aaa1-26574db2823d