483
HRF, IncHRF, Inc – FDA 483, Jul 27, 2021
Record Details
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.
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ID · 09b750fc-8202-4014-9cf9-81f50bb92772
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