# FDA 483 - Southern California Center for Reproductive Medicine - January 20, 2023

Source: https://www.globalkeysolutions.net/records/483/southern-california-center-for-reproductive-medicine/6829d250-76f8-4ee1-b7d8-881b86771c29

> FDA 483 for Southern California Center for Reproductive Medicine on January 20, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Southern California Center for Reproductive Medicine
- Inspection Date: 2023-01-20
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: The FDA issued a Form 483 to Southern California Center for Reproductive Medicine, a reproductive fertility center in Newport Beach, CA, following an inspection. The inspection revealed significant deficiencies in donor screening for communicable diseases, including West Nile Virus, HIV, Hepatitis B, and CJD/TSE. Additionally, the firm lacked adequate procedures for donor eligibility and failed to maintain donor anonymity in accompanying records.

## Related Officers

- [Celeta S. Coves](https://www.globalkeysolutions.net/people/celeta-s-coves/d0f63577-a6e4-4872-b06c-a024188a04ba)

Company: https://www.globalkeysolutions.net/companies/southern-california-center-for-reproductive-medicine/0dfcf918-5299-4364-bcee-9a05e8a21647

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