# FDA 483 - St Luke's Hospital Assisted Reproductive Technology Lab - August 18, 2021

Source: https://www.keypedia.com/records/483/st-lukes-hospital-assisted-reproductive-technology-lab/5e951df9-155f-413a-8152-1b5c53f73919

> FDA 483 for St Luke's Hospital Assisted Reproductive Technology Lab on August 18, 2021. 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: 2021-08-18
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: St Luke's Hospital Assisted Reproductive Technology Lab in Chesterfield, MO, was inspected regarding its reproductive HCT/P operations. The inspection revealed multiple significant issues related to donor eligibility, including inadequate testing and screening for communicable diseases, failure to retest donors, and insufficient quarantine procedures for HCT/Ps. Several of these conditions were noted as repeated objectionable conditions from previous inspections, indicating a persistent lack of compliance.

## Related Documents

- [483 - 2019-05-23](https://www.keypedia.com/records/483/st-lukes-hospital-assisted-reproductive-technology-lab/5bcc4ada-d14e-4244-9d7a-87066b983be3)

## Related Officers

- [William F. Lagud](https://www.keypedia.com/people/william-f-lagud/c90c4bd6-bb56-4a60-a5f8-cbc648bb8dbe)

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

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