# FDA 483 - Cincinnati Childrens Hospital Medical Center Division of Gynecology - July 12, 2023

Source: https://www.keypedia.com/records/483/cincinnati-childrens-hospital-medical-center-division-of-gynecology/2730101c-fe3d-47ad-bc59-a5cb115816d8

> FDA 483 for Cincinnati Childrens Hospital Medical Center Division of Gynecology on July 12, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Cincinnati Childrens Hospital Medical Center Division of Gynecology
- Inspection Date: 2023-07-12
- Product Type: biologics
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Cincinnati Childrens Hospital Medical Center Division of Gynecology in Cincinnati, OH, revealed significant deficiencies in their screening and testing of ovarian tissue donors. The firm used unapproved test kits for communicable disease agents and failed to adequately screen donors for risk factors of communicable diseases, including missing critical questions on donor history questionnaires. These issues indicate a failure to ensure the safety and eligibility of donated reproductive tissue.

## Related Officers

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

Company: https://www.keypedia.com/companies/cincinnati-childrens-hospital-medical-center-division-of-gynecology/1c3f01bd-1659-465b-bdea-ed57dbc61700

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