Kentucky Blood Center IncSeptember 18, 2023

FDA 483 - Kentucky Blood Center Inc - September 18, 2023

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Kentucky Blood Center Inc, a blood bank in Lexington, KY, was cited for an unacceptable method for requalifying deferred donors. The firm re-entered a donor who was previously HCV repeat reactive using only one anti-HCV screening test, contrary to FDA's requirement for two different, licensed tests. This lapse resulted in the distribution of red cell and plasma units from this improperly re-entered donor.

Company: Kentucky Blood Center Inc
Inspection Date: September 18, 2023
Product Type: Biologics
Office: Cincinnati District Office
Person: Jennifer L. Sheehan

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ID · 5852aaf7-e268-4842-931e-afdfcb888bd6