FDA 483 - St Luke's Hospital Assisted Reproductive Technology Lab - May 23, 2019

An FDA inspection of St Luke's Hospital Assisted Reproductive Technology Lab in Chesterfield, MO, revealed a significant deficiency in donor screening practices. The firm failed to perform NAT testing for West Nile Virus on oocyte donors during peak transmission months in 2017 and 2018. This indicates a failure to test donors for evidence of infection with relevant communicable disease agents.