FDA 483 - VIOS - February 03, 2107

An FDA inspection of Center For Reproductive Health/Joliet IVF LLC in Crest Hill, Illinois, revealed significant deficiencies in their human reproductive tissue operations. The firm failed to properly determine and document oocyte donor eligibility, including incomplete physical assessments and medical history interviews. Additionally, donor eligibility records were found to be inaccurate, with altered and conflicting dates, and the firm did not follow its own procedures for screening donors for infection.