FDA 483 - Center for Human Reproduction - February 23, 2016

An FDA inspection of the Center for Human Reproduction in Manhasset, NY, identified significant issues with their anonymous oocyte donor program. The firm failed to establish and follow adequate procedures for screening and determining donor eligibility, including proper documentation and updating of donor information. These deficiencies raise concerns about the thoroughness of donor screening for communicable diseases and the accuracy of critical donor eligibility records.