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

An FDA inspection of Banco Vida Corp., a firm involved in the collection, processing, and storage of human cells, tissues, and cellular and tissue-based products (HCT/Ps) like umbilical cord blood and tissue, was conducted from September 9 to September 18, 2019, in San Juan, Puerto Rico. The inspection followed Compliance Program CP 7341.002, focusing on HCT/P regulations including 21 CFR 1271.50(b)(1) and 1271.80(c). The inspection revealed significant concerns outlined in a Form FDA 483. Key violations included the failure to adequately screen HCT/P donors for communicable disease risk factors, specifically for Zika virus (ZIKV) and Creutzfeldt-Jakob Disease (CJD). Donors from ZIKV-risk areas were deemed eligible, and the firm lacked established procedures for screening these donors, particularly for first and second-degree blood relatives. Furthermore, Banco Vida Corp. used communicable disease agent tests that were not FDA-licensed, approved, or cleared for tissue donors, such as an unapproved Syphilis IgG test and a ZIKV test cleared only for blood, not tissue. The laboratory performing some of these tests was also unregistered with the FDA. Management, including the Tissue Services Manager and CEO, acknowledged the observations and committed to providing a written response within 15 business days, detailing corrective actions to address these serious non-compliance issues and ensure adherence to federal regulations.