FDA 483 - Reproductive Care Center - February 11, 2022

An FDA inspection of Reproductive Care Center in Sandy, UT, a human tissue reproductive establishment, identified a significant issue regarding donor specimen collection. The firm failed to collect oocyte and sperm donor specimens for relevant communicable disease agents and diseases (RCDADs) testing within the required timeframes for both anonymous oocyte and directed sperm donors. This lapse resulted in the use of improperly tested specimens for creating a fertilized oocyte that was subsequently transferred into a gestational carrier.