FDA 483 - Steven D. Folkerth, M.D. - January 13, 2023

The FDA inspected Clinical Research Center LLC in Dayton, OH, and identified significant deviations from investigational plans and inadequate record-keeping. Observations included the enrollment of ineligible subjects, incorrect administration of investigational product, failures in pharmacokinetic blood sampling, and unreported concomitant medications. Additionally, investigational drug disposition records were found to be inaccurate.