FDA 483 - Gary Boone - April 03, 2018

An FDA inspection of Gary Boone, M.D. Clinical Investigator in San Diego, CA, revealed significant deficiencies in the conduct and oversight of a clinical investigation. The Principal Investigator failed to adequately supervise study activities, allowing unqualified staff to perform critical tasks such as obtaining informed consent and assessing adverse events. Additionally, the firm failed to maintain accurate case histories, with discrepancies in adverse event reporting and timing of PI assessments.