FDA 483 - John M. Kirkwood, MD - October 21, 2024

An FDA inspection of John M. Kirkwood, MD, a clinical investigator in Pittsburgh, revealed significant issues with adherence to investigational plans and maintenance of accurate study records. Specifically, the inspection found failures in collecting and reviewing critical safety lab data and discrepancies in dose administration documentation for subjects. These findings indicate a lack of proper oversight and record-keeping during clinical trials.