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

The FDA issued a Warning Letter to Banco Vida Corporation and Laboratorio Banco Vida following inspections in September 2019, identifying significant violations related to their manufacture and distribution of human umbilical cord blood (HCT/Ps) and cord blood intermediates. The HCT/Ps are regulated as drugs and biological products because they do not meet the criteria for regulation solely under 21 CFR Part 1271, specifically failing homologous use and metabolic activity requirements (21 CFR 1271.10(a)(2) and (a)(4)). A major violation is the marketing of these unapproved biological products without a valid biologics license application (BLA) or an Investigational New Drug (IND) application in effect (42 U.S.C. 262(a), 21 U.S.C. 355(i)).

Additional significant deviations from current good manufacturing practice (CGMP) and current good tissue practice (CGTP) were observed. These include failure to screen donors for relevant communicable disease agents like Zika virus (ZIKV) and transmissible spongiform encephalopathy (21 CFR 1271.75(a) and (d)), inadequate procedures to prevent microbiological contamination (e.g., unvalidated aseptic processes, lack of gowning procedures, poor personnel practices), and insufficient written procedures for production and process control (e.g., unvalidated manufacturing, use of R&D/expired reagents, no time limits). Furthermore, the firm lacked adequate cleaning and maintenance procedures for equipment, did not conduct environmental and personnel monitoring, and had inaccurate batch records. The FDA deemed the firm's responses inadequate, emphasizing the significant safety concerns posed by these deficiencies. The firm must promptly correct all violations to avoid further regulatory action.