FDA 483 - Fertility Answers LLC - December 06, 2022

Fertility Answers LLC in Lafayette, LA, received a Form FDA 483 for deficiencies in donor screening and eligibility determination for human cells, tissues, and cellular and tissue-based products (HCT/Ps). The inspection revealed failures to screen for Zika virus risk factors, properly document donor eligibility, and ensure communicable disease testing was performed by a CLIA-certified laboratory. These observations indicate a need for improved donor qualification processes.