FDA 483 - Center For Advanced Reproductive Medicine & Fertility - July 19, 2019

The FDA inspected Center For Advanced Reproductive Medicine & Fertility in Edison, NJ, a human reproductive tissue establishment. The inspection revealed that the firm failed to test multiple anonymous oocyte donors for West Nile Virus, a relevant communicable disease agent, before determining their eligibility. Additionally, the firm's standard operating procedures were found to be deficient as they did not include West Nile Virus in the list of required infectious disease tests for gamete donors.