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 issues with donor 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 screening and testing. These findings indicate serious deficiencies in the facility's donor screening processes.