FDA EIR - Michael W. Harris, D.O. - May 03, 2011

A comprehensive FDA inspection of Michael Harris, associated with Aspen Clinical Research in Orem, UT, was conducted from March 21, 2011, to May 3, 2011. This was a high-priority, for-cause inspection initiated by a complaint and a request from the Division of Psychiatry Products. The inspection, which covered two specific Investigational New Drug (IND) studies and additional clinical trials, focused on compliance with regulatory guidelines for Clinical Investigators and Sponsor-Investigators (Compliance Program 7348.811).

The investigation uncovered serious and persistent deviations from regulatory requirements and Good Clinical Practices (GCPs). Specifically, issues such as fraud, scientific misconduct, significant violations related to human subject protection, and adverse event reporting discrepancies were substantiated. As a result, an FDA Form 483 detailing the observations was issued to Dr. Harris. Regulatory sanctions, including potential debarment, disqualification, Warning Letters, and data rejection, were discussed. The case was classified as Official Action Indicated (OAI), and the Office of Criminal Investigations (OCI) was contacted. Dr. Harris provided a written response to the FDA's findings.