Ignatius P. Godoy, M.D. – FDA EIR, Jun 8, 2018

An FDA Bioresearch Monitoring (BIMO) inspection of Clinical Investigator Ignatius P. Godoy, M.D., located in Paramount, CA, was conducted from May 29 to June 8, 2018. This high-priority inspection, under CP 7348.811 for a Biologics License Application, assessed compliance with Good Clinical Practice regulations, particularly 21 CFR 312.60, concerning a Phase 3 influenza vaccine study. The inspection uncovered numerous protocol deviations and deficiencies, resulting in the issuance of an FDA Form 483. Key observations included the enrollment of subjects who met exclusion criteria due to active infections or use of prohibited medications. Additionally, unnecessary blood tests were performed, subjects were improperly randomized based on vaccination history, and vaccine administration occurred outside specified dosing windows, including one dose from a refrigerator that experienced a temperature excursion. Significant issues were also noted in record-keeping, with incomplete, inaccurate, and non-contemporaneous source documents, and failures to conduct timely follow-up phone calls. Informed consent documentation also presented discrepancies. These findings indicate a notable departure from the approved investigational plan and regulatory standards, necessitating a comprehensive response and corrective actions from the clinical investigator.