483
University of Miami Infertility CenterFDA 483 - University of Miami Infertility Center - June 13, 2019
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
Open in Dashboard
ID · 6fc7b1d9-69c4-461a-b82e-6ec6b9b656ec