FDA 483 - Georgia Center for Reproductive Medicine - September 08, 2022

An FDA inspection of Georgia Center for Reproductive Medicine in Savannah, GA, identified significant deficiencies in donor screening and testing for reproductive tissues. The firm failed to adequately screen donors for communicable disease risk factors, including incomplete questionnaires and missing physical exams. Additionally, issues were noted with the timing of donor specimen collection and the absence of established written procedures for donor physical assessments and the release of CMV-reactive tissues.