FDA EIR - Michael W. Harris, D.O. - August 29, 2014

The Food and Drug Administration (FDA) conducted an inspection of Michael W. Harris, D.O., a Clinical Investigator at Aspen Clinical Research in Orem, UT, from August 11 to August 29, 2014. This comprehensive inspection was a high-priority data validation and for-cause follow-up, guided by the Bioresearch Monitoring Clinical Investigators regulatory framework (CP 7348.811). The inspection revealed multiple significant violations, including new issues and repeats from a prior 2011 inspection. Key findings included the failure to obtain informed consent from guardians of child participants and a general failure to conduct clinical investigations in accordance with the approved plan. This involved submitting incorrect information to Institutional Review Boards (IRBs), dispensing investigational drugs prematurely, not reporting patient safety metrics, enrolling ineligible individuals, and prescribing prohibited medication. Furthermore, the inspection identified a repeated failure to maintain adequate and accurate patient case histories, with contradictory source documents, improper review signatures, and insufficient record maintenance. Following the inspection, an FDA-483 was issued on August 29, 2014, detailing these observations. Dr. Harris was informed of his right to submit a written response within 15 business days, and potential FDA sanctions were discussed. The FDA will now classify the Official Action Indicated (OAI) and forward the report to the Center for Drug Evaluation and Research (CDER) for final classification and consideration of regulatory actions.