FDA EIR - Frederick L. Locke, M.D. - July 17, 2017

An FDA clinical investigator inspection of Frederick L. Locke, MD, based in Tampa, FL, occurred from July 11 to July 17, 2017. The inspection, conducted under the Clinical Investigators and Sponsor-Investigators Program (CP 7348.811) and assigned by CBER

’s Office of Compliance and Biologics Quality, reviewed protocol (b)(4) supporting IND (b)(4). This marked Dr. Locke

’s first FDA inspection.

The inspection involved a thorough review of study documentation, including informed consent processes, subject records, and investigational product accountability for a study with 25 enrolled subjects. Overall, the inspection found no significant objectionable conditions, and consequently, no FDA-483, Inspectional Observations, was issued. However, the report noted minor deviations from the protocol, primarily consisting of out-of-window follow-up visits for subjects. Two specific informed consent issues were also identified: one subject was consented using an Informed Consent Form that had expired, and a Spanish-speaking subject was initially consented with an English form, despite a Spanish version being approved, though this subject was later re-consented with an appropriate Spanish ICF. During the close-out meeting, Dr. Locke was reminded of his regulatory obligations, but no specific corrective actions were mandated as a result of the inspection.