FDA 483 - Banco Vida Corp. - August 12, 2021

Banco Vida Corp. in San Juan, PR, was cited for failing to establish and maintain adequate procedures for screening and determining the eligibility of HCT/P donors. Specifically, the firm lacked standard operating procedures for screening blood relatives of umbilical cord blood tissue donors and did not include ZIKV risk factors in its donor screening for allogeneic umbilical cord blood tissue donors. This observation is a recurrence from a previous FDA inspection.