FDA EIR - Richard Finkel, M.D. - February 19, 2019

An FDA inspection of Clinical Investigator Richard S. Finkel, MD, in Orlando, Florida, was conducted from February 13, 2019, to December 5, 2019. This comprehensive, high-priority inspection, assigned by the Center for Biologics Evaluation and Research (CBER), focused on a gene replacement therapy protocol for Spinal Muscular Atrophy Type 1, under the regulatory framework of CP 7348.811 for Clinical Investigators. While no official Form FDA 483 (Inspectional Observations) was issued, and no significant objectionable practices were found, the inspection identified several areas for process enhancement. These included an incomplete listing of study personnel performing specific tasks on the delegation log, inadequate security for study documents in an accessible office, the need to certify printed source documents as original copies, and broad access to investigational products by pharmacists not explicitly listed on the study's delegation log. In response, Dr. Finkel committed to ensuring all personnel receive appropriate protocol training, securing study documents with dedicated lockable storage, properly certifying printed source records, and adjusting investigational product storage and access protocols to align with delegated responsibilities. The inspection concluded without formal observations or warnings.