FDA 483 - Advanced Fertility Associates Medical Group, Inc. - May 01, 2025

An FDA inspection of Advanced Fertility Associates Medical Group, Inc. in Santa Rosa identified significant deficiencies in their donor screening processes for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P). The firm failed to adequately screen donors for communicable disease risk factors and lacked comprehensive procedures for determining donor eligibility. These observations indicate a potential risk to the safety and quality of HCT/P products.