FDA 483 - DCI Donor Services dba Tennessee Donor Services - September 29, 2023

An FDA inspection of DCI Donor Services dba Tennessee Donor Services in Nashville, TN, revealed that the firm failed to verify its standard operating procedures for donor eligibility determination were consistent with current CGTP regulations. Specifically, the firm used a contracted SOP that did not adequately screen for sepsis, a relevant communicable disease agent, leading to the recovery and release of tissues from approximately 99 donors diagnosed with sepsis.