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

Banco Vida Corp. in San Juan, PR, received a Form 483 with four observations related to deficiencies in donor screening and testing for human cells, tissues, and cellular and tissue-based products (HCT/Ps). The firm failed to adequately screen donors for communicable disease risk factors, including ZIKV and Creutzfeldt-Jacob Disease (CJD), and lacked proper procedures for donor eligibility determination. Additionally, the firm used an uncleared test for syphilis screening.