FDA 483 - The Center For Human Reproduction d.b.a. American Infertility of New York, P.C. - May 01, 2024

An FDA inspection of The Center For Human Reproduction d.b.a. American Infertility of New York, P.C. in New York, NY, revealed significant deficiencies in donor screening, eligibility determination, record-keeping, and labeling of human cells, tissues, and cellular and tissue-based products (HCT/Ps). The firm failed to adequately screen oocyte donors for communicable disease risks, maintain accurate donor records, establish procedures for directed semen donors, and properly label HCT/Ps from ineligible donors. These issues indicate a moderate level of severity regarding patient safety and regulatory compliance in reproductive human tissue handling.