FDA 483 - Fertility Answers LLC - December 08, 2022

Fertility Answers LLC, a fertility clinic in Baton Rouge, LA, received a Form 483 for three observations related to donor screening and eligibility for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The inspection found deficiencies in screening donors for communicable disease risks, including ZIKV, documenting donor eligibility, and ensuring contract laboratories performing communicable disease testing were CLIA certified. These issues indicate a moderate level of non-compliance with HCT/P regulations.