FDA EIR - Banco Vida Corp. - August 12, 2021

An FDA inspection of Banco Vida Corp., a hematopoietic stem/progenitor cell (HPC) firm located in San Juan, PR, was conducted from July 13 to August 12, 2021. This inspection served as a compliance follow-up to two Warning Letters issued in March and August 2020, which stemmed from a September 2019 inspection. The prior inspection cited numerous violations under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act, including inadequate donor screening for communicable disease agents, use of unapproved testing, and a failure to establish and maintain standard operating procedures (SOPs) for donor screening and eligibility determination. While Banco Vida Corp. had corrected most previous observations, the 2021 inspection, conducted under Compliance Program CP 7341.002 for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), identified a recurring critical deficiency. The company failed to establish and maintain comprehensive SOPs for screening HCT/P donors, specifically for autologous and family-related tissue donations, and its procedures lacked adequate inclusion of Zika virus risk factors for allogeneic donors. The firm's management acknowledged the observations on the issued FDA Form 483 and committed to creating and implementing the necessary SOPs for donor screening and eligibility, including updating procedures to incorporate Zika risk factors, with a written response promised within 15 business days.