FDA 483 - Henry Ford Hospital - July 19, 2019

Henry Ford Hospital in Detroit, MI, a blood bank, was cited for failing to standardize equipment used in the processing of blood and blood components. An irradiator was found to be incorrectly programmed, leading to improper radiation doses for approximately (b) (4) units of blood over a two-year period. This indicates a significant deviation from established standard operating procedures for equipment maintenance and use.