FDA 483 - The New York Fertility Center - February 27, 2019

The New York Fertility Center in Flushing, NY, received a Form 483 with four observations related to deficiencies in donor eligibility determination and communicable disease testing for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to adequately test donors for relevant communicable diseases like West Nile Virus, screen for Zika Virus risk factors, and properly document testing procedures and laboratory certifications. These issues indicate significant concerns regarding the safety and quality of HCT/Ps.