FDA 483 - Carter BloodCare at Hulen - October 28, 2022

Carter Bloodcare at Hulen, a blood donor center in Fort Worth, TX, was cited for failing to ensure proper donor acknowledgment of risks and hazards for apheresis donation procedures. Two donors provided three apheresis products without documented consent regarding the procedure's risks, leading to the distribution of these products to hospitals. This indicates a significant lapse in donor safety protocols and documentation.