# FDA 483 - Ohio Fertility Providers LLC - May 15, 2025

Source: https://www.globalkeysolutions.net/records/483/ohio-fertility-providers-llc/b163b6ff-44e6-4d04-8c43-13a5e72b6dfe

> FDA 483 for Ohio Fertility Providers LLC on May 15, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ohio Fertility Providers LLC
- Inspection Date: 2025-05-15
- Product Type: biologics
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Ohio Fertility Providers LLC in Cincinnati, OH, a human reproductive tissue facility, revealed two significant observations. The firm failed to quarantine HCT/Ps until donor-eligibility determinations were complete, resulting in the transfer of oocytes from a donor with an incomplete history. Additionally, HCT/Ps from donors with incomplete eligibility requirements were not prominently labeled with appropriate warning statements regarding communicable disease risk.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/ohio-fertility-providers-llc/a780a743-9a55-470f-93ea-1807873a4fa7

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