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