FDA 483 - Center for Reproductive Health Fertility Laboratory of Nashville - March 01, 2019

The FDA inspected the Center for Reproductive Health Fertility Laboratory in Nashville, TN, and found three significant issues related to human cells, tissues, and cellular and tissue-based products (HCT/P) donor eligibility. Specifically, the firm determined donor eligibility prior to receiving communicable disease test results, failed to test certain oocyte donors for West Nile Virus, and lacked written procedures for West Nile Virus testing. These observations indicate deficiencies in donor screening and testing practices.