FDA 483 - University of Miami Infertility Center - June 13, 2019

The University of Miami Reproductive and Fertility Center received an FDA Form 483 for failing to establish and maintain procedures for donor eligibility screening of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). This included specific deficiencies in screening for ZIKV, West Nile Virus NAT, and HBV NAT. This is a repeat deficiency, indicating a persistent issue.