FDA 483 - Clinical Laboratories of Hawaii Inc - May 06, 2025

Clinical Laboratories of Hawaii Inc, a blood bank in Hilo, Hawaii, was cited for failing to maintain adequate storage and distribution records during an FDA inspection. Specifically, the firm did not ensure physician signatures on emergency release records for blood products that had left blood bank control. This deficiency was noted in multiple instances across 2024 and 2025, affecting several units of O-negative red blood cells.