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

Collaborative Laboratory Services, LLC-Saint Francis Campus in Hartford, CT, a blood bank and transfusion services facility, was cited for a single observation regarding inadequate record-keeping during an FDA inspection. The firm failed to maintain complete records, specifically physician signatures, for emergency blood product transfusions as required by their standard operating procedures. This indicates a deficiency in ensuring proper documentation for critical patient safety procedures.