FDA 483 - Sloan W. Rush, M.D. - January 26, 2023

Sloan W. Rush, M.D., a Sponsor Investigator in Amarillo, TX, was cited for significant deficiencies during an FDA inspection from January 23-26, 2023. The inspection revealed failures in maintaining adequate and accurate case histories related to informed consent, including issues with document retention and proper consent procedures. Additionally, the firm lacked adequate investigational drug disposition and accountability records.