Carter BloodCare at HulenOctober 28, 2022

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

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Record Details

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.

Company: Carter BloodCare at Hulen
Inspection Date: October 28, 2022
Product Type: Biologics
Office: Division of Human and Animal Food Operations - West III
Person: Decarlos A. Gomez

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ID · 3c981795-73df-4c5a-a6da-569ff18675fd