FDA 483 - Banco Vida Corp. - September 18, 2019

During an FDA inspection conducted from September 9-18, 2019, at Banco Vida Corp., a human tissue establishment, significant deficiencies in donor screening and operational procedures were observed. The inspection revealed that the company failed to adequately screen allogeneic tissue donors for communicable disease risks, including Zika Virus (ZIKV) exposure related to residence or travel in risk areas. Donor questionnaires also lacked critical inquiries regarding Creutzfeldt-Jakob Disease (CJD) history and specific travel-related CJD risk factors for an extended period.

Furthermore, Banco Vida Corp. was found to have deemed donors eligible who resided in ZIKV risk areas, and their umbilical cord blood products were released for transplantation. The firm lacked established and maintained standard operating procedures (SOPs) for screening and eligibility determination of umbilical cord blood donors, particularly for first and second-degree blood relatives, and for ZIKV risk factors. Additionally, no SOPs were in place for screening tissues when collaborating with contracting firms. Finally, the company utilized a non-FDA-licensed or cleared test for syphilis screening for at least one umbilical cord blood donor.

These observations indicate non-compliance with regulations for human cells, tissues, and cellular and tissue-based products, which mandate rigorous donor screening and testing to prevent disease transmission. Banco Vida Corp. is required to implement comprehensive corrective actions to address these systemic issues, ensuring all donor screening protocols, eligibility determinations, and testing methods meet regulatory standards.