FDA 483 - Columbia University Fertility Center - November 28, 2022

An FDA inspection of Columbia University Fertility Center in New York revealed significant deficiencies in their handling of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The facility failed to properly determine donor eligibility, maintain confidential donor records, ensure communicable disease testing was performed by certified laboratories, and establish adequate screening procedures. These issues indicate a lack of compliance with regulations governing reproductive human tissue processing.