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

During an inspection conducted from July 13 to August 12, 2021, the Food and Drug Administration (FDA) issued a Form 483 to Banco Vida Corp., a human tissue establishment located in San Juan, PR. The inspection identified significant deficiencies in the company's procedures for screening and determining the eligibility of human cells, tissues, and cellular and tissue-based product (HCT/P) donors.

Specifically, the FDA observed that Banco Vida Corp. had not established or maintained adequate standard operating procedures (SOPs) for the comprehensive screening and donor eligibility determination of first- and second-degree blood relatives of umbilical cord blood (UCB) tissue donors. This is particularly concerning as the firm had collected, processed, and stored a substantial number of UCBs and UCB tissues since October 2019. Furthermore, the firm's existing SOP for donor screening, titled "QM-020 Donor Suitability and Infectious Disease Testing," failed to include necessary screening for Zika virus (ZIKV) risk factors for allogeneic umbilical cord blood tissue donors, despite shipping multiple products to customers for further manufacturing.

These issues are critical as they directly impact the safety and quality of tissue products. The FDA highlighted that the lack of proper donor screening procedures for HCT/Ps was a recurrent observation, previously noted during a September 2019 inspection. Banco Vida Corp. is required to address these deficiencies promptly by implementing robust corrective and preventive actions to ensure compliance with federal regulations governing human tissue establishments and to safeguard public health.