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

Source: https://www.keypedia.com/records/483/ohio-fertility-providers-llc/ccb74f20-0abf-421b-a6ad-63f5f5148b57

> 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: FDA District Office — Cincinnati, Ohio
- Summary: An FDA inspection of Ohio Fertility Providers LLC in Cincinnati, OH, revealed two significant observations regarding the handling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to quarantine HCT/Ps until donor eligibility was complete and did not properly label HCT/Ps with incomplete donor history questionnaires with required warning statements, potentially exposing recipients to risks.

## Related Documents

- [483 - 2025-05-15](https://www.keypedia.com/records/483/ohio-fertility-providers-llc/b163b6ff-44e6-4d04-8c43-13a5e72b6dfe)

## Related Officers

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

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

Office: https://www.keypedia.com/offices/fda-district-office-cincinnati-ohio/b4972fd9-9db9-4cc6-9a4c-0146959c9d74