# FDA 483 - New Infertility Center of St Louis - April 22, 2026

Source: https://www.keypedia.com/records/483/new-infertility-center-of-st-louis/11ecdbb7-f77d-4847-bb2d-9dc3b38f848f

> FDA 483 for New Infertility Center of St Louis on April 22, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: New Infertility Center of St Louis
- Inspection Date: 2026-04-22
- Product Type: biologics
- Office Name: Kansas City District Office
- Summary: An FDA inspection of New Infertility Center of St Louis in Chesterfield, MO, revealed critical deficiencies in their Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) program. The firm failed to adequately screen oocyte donors for communicable disease risks, improperly determined donor eligibility despite incomplete screening, and maintained inadequate procedures for ensuring compliance with donor eligibility requirements. These issues indicate a significant risk regarding the safety and suitability of donated oocytes.

## 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/new-infertility-center-of-st-louis/ebf14e70-8bfd-4343-9f9c-53c0782a3024

Office: https://www.keypedia.com/offices/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79