# FDA 483 - Billings Clinic Fertility Specialists - February 26, 2025

Source: https://www.keypedia.com/records/483/billings-clinic-fertility-specialists/7326366d-89b6-4069-962e-a587389b7e30

> FDA 483 for Billings Clinic Fertility Specialists on February 26, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Billings Clinic Fertility Specialists
- Inspection Date: 2025-02-26
- Product Type: biologics
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: 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.

## Related Officers

- [Emily S. McGann](https://www.keypedia.com/people/emily-s-mcgann/43891ff3-bd70-4337-b61c-e16cc7ad0468)

Company: https://www.keypedia.com/companies/billings-clinic-fertility-specialists/72cd8733-dd65-4cae-89e6-c8d85dbcdfcc

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822