Incinta Fertility Center, LLC – FDA 483, Feb 24, 2025

Incinta Fertility Center, LLC in Torrance, CA, was cited for significant deficiencies in its handling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The inspection revealed failures in labeling HCT/Ps from ineligible donors, inadequate screening procedures for communicable disease risks, and improper maintenance of donor records that included personally identifiable information for anonymous donors. These issues indicate a lack of control over critical aspects of donor eligibility and HCT/P management.