Banco Vida Corp. – FDA EIR, Aug 12, 2021

An FDA inspection of Banco Vida Corp., a hematopoietic stem/progenitor cell (HPC) firm in San Juan, PR, was conducted between July 13 and August 12, 2021. This follow-up inspection addressed significant deviations from regulatory requirements highlighted in two previous Warning Letters from March and August 2020. The inspection was performed under Compliance Program CP 7341.002 for Human Cells, Tissues, and Cellular and Tissue-Based products (HCT/Ps), indicating a focus on regulations related to these biological materials. The primary and recurring violation identified was the company's failure to establish and maintain adequate standard operating procedures for screening HCT/P donors. This included lacking procedures for determining donor eligibility for autologous and family-related tissues, and an inadequate inclusion of Zika virus risk factors in screening protocols for allogeneic donors, despite Puerto Rico's reported Zika cases. The previous Warning Letters had also cited issues such as insufficient donor screening for communicable diseases, inadequate environmental controls, and unvalidated processes. Although some voluntary corrections regarding donor screening questions were made, the core procedural deficiency persisted. Banco Vida Corp.'s management acknowledged the observations, committing to develop and implement the necessary screening procedures and update existing ones to incorporate Zika risk factors. The FDA emphasized the need for a formal written response and outlined potential legal sanctions should compliance not be achieved.