FDA 483 - Right Cell, LLC - August 03, 2021

An FDA inspection of Right Cell, LLC in Sandy, UT, revealed a significant issue regarding donor screening practices. The firm failed to adequately screen donors of placenta and umbilical cord tissue for risk factors of communicable disease agents, specifically West Nile Virus Infection. This deficiency was noted in their use of the "Human Birth Tissue/Blood Maternal Risk Questionnaire (MRQ)" form, which did not sufficiently screen 14 donors.