FDA EIR - Augusto E. Focil, M.D. - August 27, 2021

An FDA inspection of Augusto E. Focil, MD (FOMAT Medical Research, Inc.) was conducted from August 23-27, 2021. This high-priority Bioresearch Monitoring (BIMO) review, under compliance program 7348.811 for Clinical Investigators, evaluated two investigational new drug (IND) studies supporting a Biologics License Application (BLA). The inspection resulted in a Form FDA 483, Inspectional Observations, detailing several significant issues. Main violations included inadequate source documentation, specifically the failure to ensure records were consistently attributable and contemporaneously created. Additionally, the investigator failed to routinely conduct or document pregnancy tests for women of childbearing potential before study drug administration, and did not consistently evaluate all laboratory test results, such as abnormal D-dimer and ferritin values. The legibility of the clinical investigator’s handwritten source documentation was also noted. The site had previously faced closure by the sponsor in November 2020 due to data integrity and oversight concerns. The clinical investigator acknowledged the observations and committed to submitting a written response to the FDA by September 20, 2021, emphasizing the need for robust adherence to Good Clinical Practice regulations in clinical trials.