FDA 483 - Viera Fertility Center - June 05, 2019

An FDA inspection of Viera Fertility Center in Melbourne, FL, revealed a significant deficiency in their documentation practices. The firm failed to adequately document procedures for testing, screening, and determining donor eligibility for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). This issue specifically impacts their processes for anonymous and directed egg and sperm donors.