Billings Clinic Innovative FertilityJuly 14, 2023

FDA 483 - Billings Clinic Innovative Fertility - July 14, 2023

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An FDA inspection of Billings Clinic Innovative Fertility identified a critical lapse in donor screening procedures. The firm failed to adequately screen reproductive tissue donors for communicable disease agents and diseases, including a specific instance where Zika Virus screening was omitted and another where no donor risk assessment was performed. This indicates a significant concern regarding the safety and eligibility of reproductive tissue donors.

Company: Billings Clinic Innovative Fertility
Inspection Date: July 14, 2023
Product Type: Other
Office: Division of Human and Animal Food Operations - West VI
Person: Richard T. Riggie (investigator)

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ID · 9eeb2385-66df-4cde-9777-f8bdfcd4eafa