FDA 483 - Blood Connection Incorporated (The) - January 13, 2026

The Blood Connection - Lexington, a donor center and blood bank, was cited for failing to thoroughly investigate and document recurring high temperature alarms in a refrigerator storing blood and blood products. For an eight-month period, personnel silenced hundreds of alarms without proper documentation or root-cause analysis, leading to blood components being stored outside required temperature specifications. This indicates significant deficiencies in quality control and record-keeping practices.