FDA 483 - Stephen A. Tilles, M.D. - October 31, 2019

The FDA inspected Seattle Allergy and Asthma Research Institute, a clinical investigator, and found significant deviations from investigational plans and good clinical practices. Observations included numerous instances of study procedures not being followed, such as incorrect drug dosing, unapproved protocol changes, and missed visits. Additionally, the firm failed to maintain accurate case histories, including the use of altered informed consent forms, and lacked adequate investigational drug accountability records.