FDA 483 - InVia Fertility Specialists, PLLC - September 09, 2022
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InVia Fertility Specialists, PLLC, a reproductive tissue establishment in Hoffman Estates, IL, was cited for multiple deficiencies related to donor eligibility and communicable disease screening during an FDA inspection. Observations included failures to test oocyte donors for relevant communicable disease agents like West Nile Virus, inadequate screening for risk factors, and incomplete standard operating procedures for donor eligibility determination. These issues indicate a significant lapse in ensuring the safety of reproductive tissues.
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