FDA 483 - C.A.R.E. Fertility - April 11, 2019

An FDA inspection of C.A.R.E. Fertility in Glendale, CA, revealed a significant concern regarding donor eligibility. The firm failed to determine donors ineligible despite evidence of risk factors or clinical signs of communicable disease agents. This included accepting donors with Zika virus exposure risks and those who had not completed required medical history interviews or physical assessments.