FDA 483 - The New York Fertility Center - September 23, 2022

The New York Fertility Center in Flushing, NY, was cited for multiple deficiencies related to its handling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to properly label HCT/Ps from donors with incomplete eligibility determinations and did not clearly identify quarantined HCT/Ps. Additionally, the center lacked adequate written procedures for the storage and limited use of products from ineligible donors.