FDA 483 - Laboratorio Banco Vida - August 12, 2021

Laboratorio Banco Vida in San Juan, PR, a human tissue establishment, was cited for three observations during an FDA inspection. The firm failed to adequately validate processing methods to reduce the risk of communicable disease transmission by HCT/Ps and did not properly investigate deviations related to microbial contamination in umbilical cord blood tissues. Additionally, the firm lacked documented procedures for handling microbial growth and failed to update manufacturing procedures with necessary corrective actions.