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483
•University of Virginia Health System•June 18, 2026

University of Virginia Health System – FDA 483, Jun 18, 2026

Record Details

An FDA inspection of the University of Virginia Health System's Radioactive Drug Research Committee (RDRC) in Charlottesville, VA, identified significant procedural non-compliance. Observations included the RDRC Chairman's failure to sign meeting minutes, the omission of numerical voting results for human subject protocols in meeting minutes, and the failure to submit required annual reports to the FDA. These findings indicate a lack of adherence to regulatory requirements for RDRC operations.

Company
University of Virginia Health System
Inspection date
June 18, 2026
Product type
drugs
Office
Office of Regulatory Affairs
Person
  • David L. Chon (Consumer Safety Officer/BIMO Investigator)
View Company Profile

ID · f6e33406-796f-4709-a60c-b85817e18bfd

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