FDA 483 - Midwest Sperm Bank, LLC - March 20, 2024

Midwest Sperm Bank, LLC, a human reproductive tissue and cells establishment, was cited for significant deficiencies in its donor eligibility determination processes. The firm's "Risk Behavior Assessment" questionnaire failed to accurately screen for various communicable disease risks and other deferral criteria. Additionally, the inspection revealed a lack of established procedures for screening and determining donor eligibility related to smallpox vaccination.