FDA 483 - Life IVF Center - June 04, 2025

Life IVF Center, a human reproductive tissue establishment in Irvine, CA, was cited for two observations related to donor privacy and record keeping during an FDA inspection. The firm was found to have included donor medical record numbers on HCT/P container identification codes and personal identifying information, such as first names and dates of birth, on accompanying records for anonymous oocyte donors. These practices raise concerns about the protection of donor anonymity.