FDA 483 - Kofinas Fertility Group - July 25, 2023

The Kofinas Fertility Group in New York, NY, was inspected regarding its reproductive human tissue operations. The inspection revealed significant deficiencies in determining and documenting HCT/P donor eligibility, including issues with record accuracy, legibility, and inadequate screening for infectious disease risks like Zika Virus. These findings indicate a failure to ensure the safety and suitability of donated oocytes.