FDA 483 - Patrick J. Stiff, M.D. - August 01, 2022

The FDA inspected Patrick J. Stiff, MD, Clinical Investigator in Maywood, IL, and identified three significant deficiencies in the conduct of a clinical trial. Observations included a failure to adhere to the investigational plan by enrolling a subject without required study chair consultation, improper informed consent documentation due to the use of an unapproved form, and a lack of necessary signatures on short form consent summary documents. These findings indicate serious issues with protocol adherence and informed consent processes.