# FDA 483 - Reproductive Science Center of the San Francisco Bay Area, a Medical Corporation - February 05, 2025

Source: https://www.keypedia.com/records/483/reproductive-science-center-of-the-san-francisco-bay-area-a-medical-corporation/cbff07db-0213-4553-ac2c-66e68e7bcd8d

> FDA 483 for Reproductive Science Center of the San Francisco Bay Area, a Medical Corporation on February 05, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Reproductive Science Center of the San Francisco Bay Area, a Medical Corporation
- Inspection Date: 2025-02-05
- Product Type: biologics
- Office Name: San Francisco District Office
- Summary: The FDA issued a Form 483 to Reproductive Science Center of the San Francisco Bay Area, a Medical Corporation, located in San Ramon, CA, following an inspection of their reproductive establishment. The inspection revealed significant deficiencies in the labeling and record-keeping practices for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Specifically, the firm failed to properly label HCT/Ps from ineligible donors with biohazard warnings and communicable disease risk statements, and did not include reasons for ineligibility in donor records, raising concerns about patient safety and compliance with HCT/P regulations.

## Related Officers

- [Lesley Mae P. Lutao](https://www.keypedia.com/people/lesley-mae-p-lutao/bfdcc755-28e5-4caf-91f9-b9579df4731e)

Company: https://www.keypedia.com/companies/reproductive-science-center-of-the-san-francisco-bay-area-a-medical-corporation/ed034971-e627-4eb7-8d5a-4647c482e7fe

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