# FDA 483 - Institute for Human Reproduction (IHR), SC - October 25, 2023

Source: https://www.keypedia.com/records/483/institute-for-human-reproduction-ihr-sc/dbc6f0ca-7402-4e58-a19b-ce9ec3258acb

> FDA 483 for Institute for Human Reproduction (IHR), SC on October 25, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Institute for Human Reproduction (IHR), SC
- Inspection Date: 2023-10-25
- Product Type: biologics
- Office Name: Chicago District Office
- Summary: The Institute for Human Reproduction (IHR), Sc, a reproductive facility in Chicago, IL, was cited for significant deficiencies in its human cells, tissues, and cellular and tissue-based products (HCT/P) donor eligibility and quarantine procedures. Observations included failure to quarantine HCT/Ps with incomplete donor screening, determining donors eligible despite communicable disease risk factors, and lacking proper documentation and procedures for donor screening and eligibility. These issues indicate a serious lack of control over critical processes for ensuring HCT/P safety.

## Related Documents

- [483 - 2020-02-25](https://www.keypedia.com/records/483/institute-for-human-reproduction-ihr-sc/9642218f-538b-4209-bf91-14a27e531511)

## Related Officers

- [Lesley Mae P. Lutao](https://www.keypedia.com/people/lesley-mae-p-lutao/bfdcc755-28e5-4caf-91f9-b9579df4731e)

Company: https://www.keypedia.com/companies/institute-for-human-reproduction-ihr-sc/03a1fa1e-26f4-4bf3-a2a3-66ce0542101e

Office: https://www.keypedia.com/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669