FDA 483 - The Center For Human Reproduction d.b.a. American Infertility of New York, P.C. - January 14, 2015

An FDA inspection of American Infertility of NY in New York, NY, conducted from January 6-14, 2015, identified a significant procedural deficiency. The firm lacked adequate written procedures to ensure compliance with donor eligibility requirements and to prevent the transmission of communicable diseases. This included a failure to define how staff should record and justify departures from established procedures.