FDA 483 - James E. Cain, M.D. - August 27, 2021

FMC Science, LLC, a clinical investigator in Lampasas, TX, was inspected by the FDA. The inspection revealed that an investigation was not conducted in accordance with the signed statement of investigator and investigational plan. Specifically, a subject who met the criteria for discontinuation due to a decrease in bone mineral density was not removed from study drug dosing as required by the protocol.