FDA 483 - Center for Fertility and Reproductive Endocrinology UPP - December 08, 2021

An FDA inspection of Center for Fertility and Reproductive Endocrinology UPP in Pittsburgh, PA, revealed deficiencies in donor screening practices. The firm failed to adequately screen donors for communicable disease risk factors due to an incomplete donor risk assessment questionnaire. Additionally, an ineligible donor with risk factors for communicable disease agents was determined eligible and transferred to a recipient.