FDA 483 - Midwest Fertility Specialists - November 25, 2024

Midwest Fertility Specialists, a reproductive establishment in Carmel, IN, was cited with two observations during an FDA inspection. The firm failed to adequately screen directed semen donors for relevant communicable disease agents and diseases (RCDADs) due to incomplete medical history and physical assessment forms. Additionally, the firm lacked established and maintained procedures for screening HCT/P donors, specifically regarding CJD/vCJD risk factors.