# FDA 483 - West Coast Fertility Centers, LLC - June 05, 2023

Source: https://www.globalkeysolutions.net/records/483/west-coast-fertility-centers-llc/362d39fb-fd09-48bb-aac8-821e388eb420

> FDA 483 for West Coast Fertility Centers, LLC on June 05, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: West Coast Fertility Centers, LLC
- Inspection Date: 2023-06-05
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: West Coast Fertility Centers, LLC, an HCT/P Reproductive Tissue Establishment in Fountain Valley, CA, was cited for deficiencies in donor screening during an FDA inspection. The firm failed to adequately screen oocyte and semen donors for communicable disease risk factors, specifically syphilis, using an insufficient medical history interview form. This resulted in donors being deemed eligible without proper screening, and subsequent transfer of HCT/P tissues to recipients.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/west-coast-fertility-centers-llc/fbf568e7-955e-41fa-8d4a-f884de3f5534

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