FDA 483 - Conceptions Fertility Center - September 25, 2025

Conceptions Fertility Center in Provo, UT, a human tissue reproductive establishment, received a Form 483 with five observations. The inspection revealed significant issues including failures to determine ineligible donors, improper labeling of HCT/Ps from ineligible donors, inadequate record-keeping for donor ineligibility reasons, and incorrect labeling for HCT/Ps not requiring donor eligibility. Additionally, the firm used individual names in HCT/P identification codes.