# FDA 483 - Central Coast Multispecialty Medical Group, Inc. - May 16, 2025

Source: https://www.keypedia.com/records/483/central-coast-multispecialty-medical-group-inc/622000be-ea14-4a0a-87ce-d73c575d08b6

> FDA 483 for Central Coast Multispecialty Medical Group, Inc. on May 16, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Central Coast Multispecialty Medical Group, Inc.
- Inspection Date: 2025-05-16
- Product Type: biologics
- Office Name: San Francisco District Office
- Summary: Central Coast Multispecialty Medical Group, Inc. in Monterey, CA, was cited for significant deficiencies in its human reproductive tissue donor screening and eligibility determination processes. The inspection revealed failures to deem ineligible donors with communicable disease risk factors, inadequate screening of sperm and egg donors, and a lack of comprehensive written procedures for donor eligibility. These issues, including repeat observations, indicate a serious risk to public health due to potential transmission of communicable diseases through human reproductive tissue.

## Related Documents

- [483 - 2022-04-14](https://www.keypedia.com/records/483/central-coast-multispecialty-medical-group-inc/754e23af-67d0-43ef-bf45-8c7e93f7be2d)
- [WARNING_LETTER - 2025-05-16](https://www.keypedia.com/records/warning_letter/central-coast-multispecialty-medical-group-inc/829b9c58-d408-4d9f-a9ba-2b9778e8a63b)

## Related Officers

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

Company: https://www.keypedia.com/companies/central-coast-multispecialty-medical-group-inc/d0e71d4d-0178-41e1-9295-f622a41b330a

Office: https://www.keypedia.com/offices/san-francisco-district-office/6f838e9c-aae1-4665-9c46-a51d43be02df