FDA 483 - Laboratorio Banco Vida - September 18, 2019

An FDA inspection of Laboratorio Banco Vida in San Juan, PR, revealed significant deficiencies in their human tissue establishment operations. The firm failed to establish adequate environmental controls, validate aseptic processing, maintain detailed records, and investigate deviations related to positive microbial results. These issues indicate a high risk of contamination and compromise to the quality and safety of umbilical cord blood tissues.