Humacyte Global Inc – FDA EIR, Jun 17, 2024

An FDA inspection of Humacyte Global Inc., located in Durham, NC, was conducted from June 11 to June 17, 2024. This initial inspection, assigned by the Center for Biologics Evaluation and Research (CBER) and conducted under Compliance Program 7348.810 (Bioresearch Monitoring-Sponsors and Contract Research Organizations), focused on the company's oversight of investigator study sites for its investigational biological product, the human acellular vessel (HAV SYMVESS), under protocol CLN-PRO-V005. While no FDA Form 483 (listing objectionable conditions) was issued at the inspection's conclusion, the report highlighted significant compliance issues at two study sites which resulted in enrollment holds. At Site 02, problems involved informed consent procedures and query resolution. More critically, at Site 06, a patient was implanted with an HAV from another study's inventory without proper informed consent, leading to the removal of the sub-investigator. Humacyte Global Inc. implemented corrective action plans (CAPAs) to address these issues, which included enhanced monitoring and coordination with institutional review boards (IRBs). Management was reminded of their ongoing responsibility to maintain compliance with all applicable regulations. The inspection results and exhibits will be forwarded to CBER for final review and classification.