FDA 483 - UF Reproductive Medicine at Springhill - June 06, 2019

An FDA inspection of UF Reproductive Medicine at Springhill in Gainesville, FL, a reproductive tissue establishment, identified significant deficiencies related to the processing and labeling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). Observations included inadequate labeling of HCT/Ps for which donor eligibility was not performed, specifically regarding warning statements for communicable disease risks. Additionally, the firm's procedures were found to be insufficient to ensure compliance with donor eligibility requirements, particularly concerning the use of biohazard legends for ineligible directed reproductive donors.