483
HCSC-Blood CenterHCSC-Blood Center – FDA 483, Jul 20, 2026
Record Details
An FDA inspection of HCSC-Blood Center in Bethlehem, PA, a blood bank, identified two significant observations. The firm failed to maintain adequate storage, distribution, and quality control records, specifically lacking documentation for unit inspection and temperature of returned and reissued blood products. Additionally, written standard operating procedures for blood collection were not consistently followed, as evidenced by improper handling and timing of a platelet unit.
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ID · 9274a385-7916-43d6-9b14-44ebc4f4527d
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