FDA 483 - The Center For Human Reproduction d.b.a. American Infertility of New York, P.C. - March 03, 2017

The FDA inspected American Infertility of New York, P.C. and issued a Form 483 with two observations. The inspection revealed deficiencies in donor screening procedures, specifically regarding the assessment of disease risks associated with xenotransplantation and the failure to follow established SOPs for screening HCT/P donor eligibility, including critical risk factors for infectious diseases. These issues indicate a lack of adequate controls in donor screening processes.