FDA 483 - Unity Fertility Center, LLC - September 02, 2021

An FDA inspection of Unity Fertility Center, LLC in Pasadena, CA, a human reproductive tissue establishment, revealed significant deficiencies in donor eligibility determination and procedural controls. The firm failed to properly determine and document donor eligibility based on testing results, and lacked established procedures for screening and testing HCT/P donors, including those for directed semen donors. Furthermore, the facility did not have a written procedure for releasing reproductive tissue from donors who tested reactive for cytomegalovirus (CMV).