FDA 483 - Veterans Affairs Greater Los Angeles Healthcare System RDRC - September 06, 2019

An FDA inspection of Veterans Affairs Greater Los Angeles Healthcare System RDRC in Los Angeles, CA, revealed a deficiency in record-keeping practices. The Radioactive Drug Research Committee (RDRC) failed to include the numerical results of votes on protocols involving human subjects in their meeting minutes from 2016 through 2019. This indicates a moderate severity issue related to documentation and oversight of research protocols.