FDA 483 - Baptist Health Deaconess Madisonville Inc - April 24, 2025

An FDA inspection of Baptist Health Deaconess Madisonville Inc, a blood bank, revealed two significant observations. The firm failed to thoroughly investigate unexplained ABO blood type discrepancies and did not conduct a root cause analysis. Additionally, the firm's standard operating procedures for donor phlebotomy were not adequately established or followed, specifically regarding the inversion of blood collection tubes.