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

The FDA conducted inspections of Banco Vida Corporation and Laboratorio Banco Vida from September 9-18, 2019, documenting significant deviations from Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) regulations (21 CFR 1271). Key violations include the failure to adequately screen donors for all relevant communicable disease risk factors, such as hepatitis B/C, West Nile Virus, and Zika virus, and the use of an unapproved syphilis test kit for donor screening. The firm also failed to adequately control environmental conditions, specifically lacking monitoring of the biological safety cabinet used for umbilical cord blood processing, and did not validate its HPC-C Manufacturing process. Further deficiencies involved processing HCT/Ps in a manner that risked cross-contamination, a lack of investigation into positive post-processing cultures, and inadequate procedures for donor eligibility, particularly regarding Zika virus risk. The FDA acknowledged the firm's responses but noted ongoing concerns, emphasizing that current ZIKV tests are not appropriate for HCT/Ps and that donors from ZIKV risk areas must be deemed ineligible and products labeled accordingly. The letter requires prompt corrective actions, a written response within 15 working days detailing steps taken to correct violations and prevent recurrence, and warns of potential regulatory action if non-compliance persists.