FDA 483 - University of North Carolina at Chapel Hill (UNC) RDRC - September 16, 2019

An FDA inspection of the University of North Carolina at Chapel Hill (UNC) Radioactive Drug Research Committee (RDRC) identified two observations related to record-keeping deficiencies. The RDRC failed to document numerical voting results for protocols involving human subjects in meeting minutes. Additionally, the RDRC Chairman did not sign minutes for multiple committee meetings over several years.