# FDA 483 - Global Premier Fertility Orange County LLC - April 11, 2025

Source: https://www.globalkeysolutions.net/records/483/global-premier-fertility-orange-county-llc/210bea8f-ac7d-4d04-85bb-87448c8560b8

> FDA 483 for Global Premier Fertility Orange County LLC on April 11, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Global Premier Fertility Orange County LLC
- Inspection Date: 2025-04-11
- Product Type: biologics
- Office Name: Los Angeles District Office
- Summary: An FDA inspection of Global Premier Fertility Orange County LLC, a human reproductive tissue establishment, identified three observations related to donor record management. The firm failed to adequately protect donor anonymity, document communicable disease testing certification, and maintain complete donor eligibility determinations. These deficiencies indicate significant issues in the firm's compliance with HCT/P regulations.

## Related Officers

- [Melsomar R. Ramos](https://www.globalkeysolutions.net/people/melsomar-r-ramos/395e7ddc-ed98-455a-a143-0ee5f46804f4)

Company: https://www.globalkeysolutions.net/companies/global-premier-fertility-orange-county-llc/20c9e3cc-2d6c-4aa5-95e0-3e36a6b11ae8

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