FDA 483 - The Laboratory at the Center for Advanced Reproductive Svcs - February 15, 2022

The FDA issued a Form 483 to The Laboratory at the Center for Advanced Reproductive Svcs in Farmington, CT, following an inspection from February 8-15, 2022. The inspection revealed a significant deficiency in donor screening practices, specifically concerning the incomplete or missing Zika Virus questions on their "Gamete Provider Medical History Interview Questionnaire" for oocyte and semen donors. This indicates a failure to adequately screen for communicable disease agents and diseases.