# FDA 483 - Northern California Fertility Medical Center - August 19, 2025

Source: https://www.keypedia.com/records/483/northern-california-fertility-medical-center/22b7f98b-e3a0-466a-b240-cd7cf74684ab

> FDA 483 for Northern California Fertility Medical Center on August 19, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Northern California Fertility Medical Center
- Inspection Date: 2025-08-19
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: An FDA inspection of NCFMC, a Medical Corporation, identified significant deficiencies in its human reproductive tissue establishment. The firm failed to properly determine donor eligibility, particularly concerning communicable disease risk factors, and did not adhere to manufacturer's instructions for disease agent testing. Furthermore, NCFMC lacked comprehensive and consistent written procedures for donor screening, eligibility, and the donation of various reproductive tissues.

## Related Documents

- [483 - 2025-08-19](https://www.keypedia.com/records/483/northern-california-fertility-medical-center/ed391a9d-1158-47df-a1f3-02aeedbc74e7)

## Related Officers

- [Shelley H. Beausoleil](https://www.keypedia.com/people/shelley-h-beausoleil/1212116b-e24d-4bbc-a27a-5c16334d573e)

Company: https://www.keypedia.com/companies/northern-california-fertility-medical-center/f3b09bf1-6e3d-4ec1-b524-c12a0c0777c7

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b