FDA 483 - North Carolina Center for Reproductive Medicine Inc (NCCRM) - January 26, 2023

An FDA inspection of North Carolina Center for Reproductive Medicine Inc (NCCRM) in Cary, NC, revealed significant deficiencies in determining HCT/P donor eligibility. The firm accepted multiple gamete donors despite incomplete health history screenings, positive risk factors, or lack of documentation regarding treatment or ineligibility. These practices raise concerns about the safety and suitability of the HCT/Ps processed by the facility.