FDA 483 - Michael W. Harris, D.O. - May 24, 2019

Aspen Clinical Research was cited for significant deficiencies in conducting clinical investigations, including repeated failures to ensure subjects met screening criteria, inadequate evaluation of drug screens, and non-compliance with dosing protocols. The firm also used unqualified staff for study assessments, failed to follow protocol for various activities, and submitted inaccurate information to the IRB. Additionally, issues were noted with investigational drug disposition records and the maintenance of accurate case histories.