FDA 483 - Reproductive Care Center - May 14, 2025

An FDA inspection of Reproductive Care Center in Sandy, UT, a human tissue reproductive establishment, revealed significant deficiencies in donor screening and eligibility determinations. The firm was cited for deeming HCT/P donors eligible despite identified risk factors for communicable diseases and for determining donor eligibility prior to the completion of required donor history questionnaires. These issues indicate a failure to ensure the safety and suitability of donor materials.