# FDA 483 - Louisville Reproductive Center - April 08, 2021

Source: https://www.keypedia.com/records/483/louisville-reproductive-center/872e14d0-2745-42ba-a15d-d08db1d00f46

> FDA 483 for Louisville Reproductive Center on April 08, 2021. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Louisville Reproductive Center
- Inspection Date: 2021-04-08
- Product Type: biologics
- Office Name: Cincinnati District Office
- Summary: The FDA inspection of Louisville Reproductive Center identified critical failures in donor screening and eligibility determination for human cells, tissues, and cellular and tissue-based products (HCT/Ps). The firm failed to properly screen donors for communicable diseases, including determining ineligibility for reactive donors and conducting complete screenings. Significant deficiencies were also noted in donor record-keeping and the establishment of adequate testing procedures.

## Related Documents

- [WARNING_LETTER - 2017-06-15](https://www.keypedia.com/records/warning_letter/louisville-reproductive-center/a9f1c684-be68-4d8c-8121-0eff4d117497)
- [483 - 2025-04-28](https://www.keypedia.com/records/483/louisville-reproductive-center/e470cebd-8996-4a43-9324-227bd02f7bf4)
- [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