483
St Luke's Regional Medical CenterSt Luke's Regional Medical Center – FDA 483, May 4, 2023
Record Details
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.
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ID · 5eff9746-277c-4b32-a37b-0b50474b4ea8
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