Billings Clinic Fertility Specialists – FDA 483, Feb 26, 2025
An FDA inspection of Billings Clinic Fertility Specialists in Bozeman, MT, revealed significant deficiencies in their human cells, tissues, and cellular and tissue-based products (HCT/P) program. The firm failed to properly determine donor eligibility, conduct required communicable disease testing, and ensure eligibility determinations were made by a responsible person. These issues were observed across multiple donor records, indicating a systemic problem with their donor screening and testing processes.
ID · 7326366d-89b6-4069-962e-a587389b7e30
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