FDA 483 - Cleveland Clinic Fertility Center - April 01, 2022

The FDA issued a Form 483 to Cleveland Clinic Fertility Center in Beachwood, OH, citing deficiencies related to donor testing for communicable diseases. The inspection revealed that oocyte donors were not tested for West Nile Virus over several years. Furthermore, the facility lacked established procedures for conducting and interpreting West Nile Virus testing for HCT/P donors.