FDA 483 - Billings Clinic Fertility Specialists - February 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.