# FDA 483 - Reproductive Care Center - May 14, 2025

Source: https://www.keypedia.com/records/483/reproductive-care-center/0077e765-7665-4bc3-af81-1224d846cd63

> FDA 483 for Reproductive Care Center on May 14, 2025. Product: biologics. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Reproductive Care Center
- Inspection Date: 2025-05-14
- Product Type: biologics
- Office Name: Denver District Office
- Summary: An FDA inspection of Reproductive Care Center in Sandy, UT, a human tissue reproductive establishment, revealed significant issues with donor eligibility determinations. The firm was cited for deeming HCT/P donors eligible despite identified risk factors for communicable diseases and for determining donor eligibility prior to the completion of required screening and testing. These findings indicate serious deficiencies in the facility's donor screening processes.

## Related Documents

- [483 - 2022-02-11](https://www.keypedia.com/records/483/reproductive-care-center/503d5332-a856-4dad-8b3d-a32e114c0bf9)

## Related Officers

- [Emily B. Camire](https://www.keypedia.com/people/emily-b-camire/dff5f4c6-bcbe-4ef1-ac0b-1b2701b311ef)

Company: https://www.keypedia.com/companies/reproductive-care-center/5c1374d4-9258-4ea2-814a-1184ae36b2e8

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face