FDA 483 - Banco de Sangre ASEM - June 05, 2019

An FDA inspection of Banco de Sangre ASEM, a blood bank establishment in San Juan, PR, revealed a significant issue regarding the investigation and follow-up of adverse donor reactions. The firm failed to complete final conclusions for a substantial number of donor reactions and did not follow up on some of these cases. This indicates a lapse in maintaining proper records and ensuring donor safety protocols.