# FDA 483 - Louisville Reproductive Center - April 28, 2025

Source: https://www.keypedia.com/records/483/louisville-reproductive-center/e470cebd-8996-4a43-9324-227bd02f7bf4

> FDA 483 for Louisville Reproductive Center on April 28, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Louisville Reproductive Center
- Inspection Date: 2025-04-28
- Product Type: biologics
- Office Name: Cincinnati District Office
- Summary: Louisville Reproductive Center, a human tissue establishment, was cited for three observations during an FDA inspection. The primary issues involved failures in testing semen donors for relevant communicable disease agents, including HIV, HBV, HCV, West Nile Virus, HBc, and HTLV 1 and 2. Additionally, the firm failed to quarantine Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) until donor eligibility determinations were completed.

## Related Documents

- [WARNING_LETTER - 2017-06-15](https://www.keypedia.com/records/warning_letter/louisville-reproductive-center/a9f1c684-be68-4d8c-8121-0eff4d117497)
- [483 - 2021-04-08](https://www.keypedia.com/records/483/louisville-reproductive-center/872e14d0-2745-42ba-a15d-d08db1d00f46)
- [WARNING_LETTER - 2025-04-28](https://www.keypedia.com/records/warning_letter/louisville-reproductive-center/442e539a-ef07-48cb-bca7-06d86875f243)

## Related Officers

- [Jennifer L. Sheehan](https://www.keypedia.com/people/jennifer-l-sheehan/a49c628d-6eba-4b52-bafc-70785b9ba75e)

Company: https://www.keypedia.com/companies/louisville-reproductive-center/b1b4afdf-389d-463a-9b58-d06525fee135

Office: https://www.keypedia.com/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22