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

During an inspection conducted from September 3 to September 6, 2019, at the Veterans Affairs Greater Los Angeles Healthcare System RDRC, the Food and Drug Administration (FDA) issued a Form FDA 483 report. This report, addressed to Judah B. Farahi, RDRC Chairperson, Chief Chemist, and Director of Cyclotron Facility, outlined an observation related to the firm's Radioactive Drug Research Committee (RDRC) activities. The primary observation noted was a deficiency in the committee's record-keeping practices. Specifically, the minutes from RDRC meetings held between 2016 and 2019 did not include the numerical results of votes on study protocols involving human subjects. This indicates a gap in the documentation required for oversight of research involving investigational drugs. While the FDA 483 document represents inspectional observations and not a final compliance determination, it serves to highlight conditions requiring attention. In response, the firm is expected to address this observation by implementing corrective actions to ensure comprehensive and accurate recording of RDRC meeting votes for human subject protocols, aligning with the regulatory framework enforced by the FDA under the Federal Food, Drug and Cosmetic Act.