FDA 483 - Mark R. Newton, M.D. - September 23, 2021

This FDA Form 483 was issued to Mark R. Newton, M.D. in Waterloo, IA, following an inspection from September 20-23, 2021. The inspection revealed significant deficiencies in the conduct of an investigational study, including enrollment of subjects with exclusionary criteria, failure to obtain prior IRB/sponsor approval for protocol deviations, and inaccurate reporting to the IRB. These issues indicate a lack of adherence to investigational plans and regulatory requirements, potentially impacting subject safety and study validity.