483
Clinical Laboratories of HI at Wilcox Mem Hospital (Lab)Clinical Laboratories of HI at Wilcox Mem Hospital (Lab) – FDA 483, May 9, 2025
Record Details
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.
- Inspection date
- May 9, 2025
- Product type
- biologics
- Person
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ID · 710dd3fd-cae2-4c24-91e7-2da0f6b79d28
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