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

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.