FDA 483 - Audubon Fertility, LLC - April 10, 2019

Audubon Fertility, LLC in New Orleans, LA, was inspected by the FDA from April 10-12, 2019, and received a Form 483 with two observations. The inspection revealed deficiencies related to the testing of donors for communicable disease agents and the implementation of updated donor eligibility screening procedures. Specifically, the firm failed to test an oocyte donor for West Nile Virus and had not revised procedures to include testing for West Nile Virus and screening for Zika virus.