FDA 483 - Collaborative Laboratory Services, LLC- Saint Francis Campus - August 20, 2025

Collaborative Laboratory Services, LLC-Saint Francis Campus, a blood bank and transfusion service in Hartford, CT, was cited for failing to maintain complete records for emergency transfusions. Specifically, physician signatures required by the firm's own SOP for emergency blood product releases were consistently absent. This indicates a significant lapse in adherence to established procedures for critical patient care documentation.