Michael W. Harris, D.O. – FDA EIR, Dec 15, 2015

An FDA inspection of Michael W. Harris, D.O., Clinical Investigator, operating from Aspen Clinical Research, was conducted from December 7 to December 15, 2015. This comprehensive site inspection served as a high-priority pre-approval data-validation and Good Clinical Practice (GCP) audit, falling under the Bioresearch Monitoring Compliance Program.

The inspection uncovered critical and recurring violations. Dr. Harris was cited for failing to conduct an investigation according to the signed investigator statement and investigational plan, and for failing to prepare and maintain adequate and accurate case histories. Additionally, inspectors identified inconsistent or conflicting data in source documents and continued evidence of backdating records. These observations represent repeat issues from previous FDA inspections conducted in 2011 and 2014.

Following the inspection, an FDA-483 was issued to Dr. Harris, detailing these observations. He was advised of his right to provide a written response within fifteen days. The district office has referred the matter to the CDER Office of Scientific Investigations (OSI) for thorough review, final classification, and to determine the timing for a reinspection, indicating a need for central oversight regarding these persistent compliance concerns.