FDA 483 - University of Miami Infertility Center - July 12, 2018

The FDA issued a Form 483 to the University of Miami Reproductive and Fertility Center in Miami, FL, for significant deficiencies in their donor screening and eligibility determination processes for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The inspection revealed failures to adequately screen donors for communicable disease risk factors, particularly Zika Virus, and to ensure donor eligibility was determined only after all required screening and testing were complete. Additionally, the firm lacked proper documentation for eligibility determinations and established procedures for donor screening and testing.