483
St Luke's Hospital Assisted Reproductive Technology LabFDA 483 - St Luke's Hospital Assisted Reproductive Technology Lab - May 23, 2019
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Record Details
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.
- Inspection Date
- May 23, 2019
- Product Type
- Biologics
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ID · 5bcc4ada-d14e-4244-9d7a-87066b983be3