# FDA 483 - Global Premier Fertility - Los Angeles, PC - December 08, 2025

Source: https://www.keypedia.com/records/483/global-premier-fertility-los-angeles-pc/db9541b0-f24c-4b32-aca4-34854dc31a52

> FDA 483 for Global Premier Fertility - Los Angeles, PC on December 08, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Global Premier Fertility - Los Angeles, PC
- Inspection Date: 2025-12-08
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Global Premier Fertility - Los Angeles, PC, a HCT/P Reproductive Establishment in Rolling Hills Estates, CA, revealed significant deficiencies in donor screening and record-keeping practices. The firm failed to adequately screen donors for all required relevant communicable disease agents and diseases, including West Nile Virus and variant Creutzfeldt-Jakob Disease. Additionally, procedures were not designed to ensure compliance with donor eligibility requirements, and the interpretation of communicable disease test results was not consistently documented.

## Related Officers

- [Creighton T. Tuzon](https://www.keypedia.com/people/creighton-t-tuzon/be0d09c0-59f4-48c3-9e3d-a1ceb2587e3e)

Company: https://www.keypedia.com/companies/global-premier-fertility-los-angeles-pc/6d316537-8587-4ea5-9047-aebe63aba666

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6