FDA 483 - Davies Fertility & IVF Specialists - February 21, 2020

An FDA inspection of Davies Fertility & IVF Specialists in Glenview, IL, revealed deficiencies in their procedures for human cells, tissues, and cellular and tissue-based products (HCT/Ps). The firm failed to test an anonymous oocyte donor for West Nile Virus and maintained outdated standard operating procedures that did not include screening for Zika Virus or testing for West Nile Virus in donors.