FDA 483 - Clinical Laboratories of HI at Wilcox Mem Hospital (Lab) - March 14, 2019

Clinical Laboratories of HI at Wilcox Mem Hospital (Lab) in Lihue, HI, a hospital blood bank, was cited for two observations during an FDA inspection. The inspection revealed failures to consistently follow written standard operating procedures for blood processing and compatibility testing, including issues with SOP review and QC record documentation. Additionally, the firm failed to maintain equipment used in blood processing, specifically lacking records for required irradiator inspections.