FDA 483 - Family Fertility Center - June 26, 2019

The FDA inspected Family Fertility Center in Houston, TX, and found significant issues with their donor screening and eligibility determination processes for reproductive tissues. The firm failed to adequately screen oocyte donors for communicable disease risks, including Zika virus, and did not properly document donor eligibility or retain required records. These deficiencies led to the use of tissues from donors who were not fully assessed or deemed eligible according to regulations.