FDA 483 - HRF, Inc - July 27, 2021

An FDA inspection of HRF, Inc. in Raleigh, NC, a source plasma donation center, revealed a significant deficiency in their donor screening process. The firm failed to conduct adequate medical history interviews, specifically not properly assessing risks for variable Creutzfeldt-Jakob disease and failing to include certain medications in their deferral list. This oversight impacts the safety and purity of collected blood and blood components.