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

Source: https://www.globalkeysolutions.net/records/483/st-lukes-hospital-assisted-reproductive-technology-lab/5bcc4ada-d14e-4244-9d7a-87066b983be3

> FDA 483 for St Luke's Hospital Assisted Reproductive Technology Lab on May 23, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: St Luke's Hospital Assisted Reproductive Technology Lab
- Inspection Date: 2019-05-23
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: 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.

## Related Documents

- [483 - 2021-08-18](https://www.globalkeysolutions.net/records/483/st-lukes-hospital-assisted-reproductive-technology-lab/5e951df9-155f-413a-8152-1b5c53f73919)

## Related Officers

- [Supervisory](https://www.globalkeysolutions.net/people/kathleen-b-swat/8bbaa25d-cf50-4da5-8b6c-ce32df24e978)

Company: https://www.globalkeysolutions.net/companies/st-lukes-hospital-assisted-reproductive-technology-lab/63bd6d12-e1a2-48ff-8bcb-8d49cfe90493

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8