FDA 483 - Diamond Institute for Infertility and Menopause - February 23, 2022

The FDA inspected Diamond Institute for Infertility and Menopause in Millburn, NJ, and found significant deficiencies related to donor eligibility determination and screening for communicable diseases. The firm failed to properly screen donors with reactive test results or incomplete medical histories, shipped HCT/Ps without complete eligibility, and lacked adequate screening procedures, including for Zika Virus. These issues indicate a serious risk of transmitting communicable diseases through reproductive tissues.