FDA 483 - Regents of the University of California on behalf of UCLA Fertility and Reproductive Health Center - January 11, 2023

The FDA inspected Regents of the University of California on behalf of UCLA Fertility and Reproductive Health Center in Los Angeles, CA, and identified significant deficiencies in their donor screening and eligibility determination processes. The facility failed to adequately screen oocyte and semen donors for Zika virus and did not establish proper procedures for donor eligibility. Additionally, donors were deemed eligible prior to the review of all relevant communicable disease testing records.