FDA 483 - Clinical Laboratories of HI at Wilcox Mem Hospital (Lab) - May 09, 2025

An FDA inspection of Clinical Laboratories of Hawaii at Wilcox Medical Center in Lihue, Hawaii, a blood bank, identified two observations. The firm failed to maintain equipment used in blood processing, specifically a blood irradiator, lacking complete maintenance logs for 2024 and 2025. Additionally, the firm failed to maintain storage and distribution records, with numerous emergency release records missing required physician signatures.