FDA 483 - Jones Institute for Reproductive Medicine - November 08, 2022

The FDA inspected Jones Institute for Reproductive Medicine in Norfolk, VA, and issued a Form 483 with three observations. The firm failed to adequately screen oocyte donors for communicable disease risk factors, including specific travel and transfusion history, and lacked proper questions for Zika and West Nile Virus. Additionally, HCT/Ps with incomplete donor eligibility were not appropriately labeled, and the firm did not maintain established procedures for testing and screening HCT/P donors for West Nile and Zika Viruses.