483
Banco de Sangre ASEMBanco de Sangre ASEM – FDA 483, Jun 5, 2019
Record Details
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.
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ID · b9ee2a1c-c60e-445e-98b1-a95d8dd2d560
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