FDA 483 - Kedplasma LLC - April 22, 2022

BPL Plasma, Inc. in Hot Springs, AR, a Source Plasma Collection Center, was cited for failing to adequately assess donor medical history. Specifically, their medical questionnaire and travel poster did not sufficiently screen donors for Creutzfeldt-Jacob Disease (CJD) and Variant Creutzfeld-Jacob Disease (vCJD) risks associated with travel to high-risk areas. This deficiency could adversely affect the safety, purity, or potency of collected blood components.