FDA 483 - Alabama Fertility Specialists, PC - March 15, 2023

Alabama Fertility Specialists, PC in Homewood, AL, was inspected and cited for three observations related to its handling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm lacked adequate procedures for donor screening, specifically for Zika virus risk and for releasing HCT/Ps from CMV-reactive donors. Additionally, the summary of records for HCT/Ps did not include a statement about the communicable disease testing laboratory's CLIA certification.