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

Source: https://www.keypedia.com/records/483/reproductive-care-center/d1e19619-c16e-49d2-9da7-106f643511d0

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

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## Details

- Record Type: 483
- Company Name: Reproductive Care Center
- Inspection Date: 2025-05-14
- Product Type: biologics
- Office Name: FDA District Office — Denver, Colorado
- Summary: An FDA inspection of Reproductive Care Center in Sandy, UT, a human tissue reproductive establishment, revealed significant deficiencies in donor screening and 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 donor history questionnaires. These issues indicate a failure to ensure the safety and suitability of donor materials.

## Related Documents

- [483 - 2022-02-11](https://www.keypedia.com/records/483/reproductive-care-center/503d5332-a856-4dad-8b3d-a32e114c0bf9)
- [483 - 2025-05-14](https://www.keypedia.com/records/483/reproductive-care-center/0077e765-7665-4bc3-af81-1224d846cd63)

## 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/fda-district-office-denver-colorado/1670d160-cbfd-48fd-b9c1-fbba4631fcb0