# FDA 483 - Fertility Center of Southern California - March 14, 2025

Source: https://www.globalkeysolutions.net/records/483/fertility-center-of-southern-california/9f80a61e-7d19-4bd9-ad9c-2a8caf1404a4

> FDA 483 for Fertility Center of Southern California on March 14, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Fertility Center of Southern California
- Inspection Date: 2025-03-14
- Product Type: biologics
- Office Name: Los Angeles District Office
- Summary: The FDA inspected Fertility Center of Southern California, a reproductive human tissue establishment, and identified a critical failure in donor eligibility determination. A directed donor with a documented risk factor for Creutzfeldt-Jacob Disease was improperly deemed eligible by the Medical Director, leading to the donation of oocytes and cryopreserved tissues. This indicates a significant lapse in the firm's donor screening and eligibility processes.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/irina-gaberman/c863b2de-4c64-40d2-a390-289d293e5a8f)

Company: https://www.globalkeysolutions.net/companies/fertility-center-of-southern-california/6138ad04-0569-4ded-a869-ee47332b5bfd

Office: https://www.globalkeysolutions.net/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b