FDA 483 - M FATEH & K SULTAN M D S P C - September 05, 2012

The New York Fertility Institute was cited for multiple deficiencies related to the testing, screening, and eligibility determination of anonymous oocyte donors. Observations included failure to perform required communicable disease testing, inadequate screening for risk factors, and deeming ineligible donors as eligible. Additionally, the firm lacked established procedures for donor eligibility, maintained inaccurate records, and failed to provide required documentation to the FDA.