# FDA 483 - Reproductive Care Center - February 11, 2022

Source: https://www.keypedia.com/records/483/reproductive-care-center/503d5332-a856-4dad-8b3d-a32e114c0bf9

> FDA 483 for Reproductive Care Center on February 11, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Reproductive Care Center
- Inspection Date: 2022-02-11
- Product Type: biologics
- Office Name: Denver District Office
- Summary: An FDA inspection of Reproductive Care Center in Sandy, UT, a human tissue reproductive establishment, identified a significant issue regarding donor specimen collection. The firm failed to collect oocyte and sperm donor specimens for relevant communicable disease agents and diseases (RCDADs) testing within the required timeframes for both anonymous oocyte and directed sperm donors. This lapse resulted in the use of improperly tested specimens for creating a fertilized oocyte that was subsequently transferred into a gestational carrier.

## Related Documents

- [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/denver-district-office/93b79063-390c-4759-af6c-5da7e388face