FDA 483 - InVia Fertility Specialists, PLLC - February 05, 2025

An FDA inspection of InVia Fertility Specialists, PLLC in Hoffman Estates, IL, revealed multiple deficiencies in their handling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to adequately screen and test donors for communicable diseases, maintain proper documentation for donor eligibility, and correctly label and quarantine HCT/Ps from ineligible donors. This inspection also noted a repeat violation regarding the lack of established procedures for donor testing and screening.