FDA 483 - NYC In Vitro Fertilization, P.C. - August 22, 2022

NYC In Vitro Fertilization, P.C. in New York, NY, a human reproductive tissue establishment, was cited for deficiencies in its donor screening practices. The inspection revealed that the firm failed to adequately screen anonymous oocyte donors for various communicable disease risk factors. Additionally, the firm did not establish and maintain proper procedures for determining the eligibility of HCT/P donors, indicating a lack of robust quality controls.