FDA 483 - St Luke's Regional Medical Center - May 04, 2023

An FDA inspection of St Luke's Regional Medical Center, a blood bank in Boise, ID, revealed significant deficiencies in their quality control unit, standard operating procedures, and record-keeping. The firm lacked written procedures for quality control responsibilities, investigating product deviations, and handling mislabeled blood products. Additionally, the facility failed to maintain proper records for transfusion reaction reports and complaints.