FDA EIR - IVF New York - February 03, 2010

An FDA surveillance inspection of IVF New York, a reproductive tissue facility located at 230 Central Park S, New York, NY, was conducted on February 3, 2010. The inspection assessed the company's operations as a Reproductive Tissue Facility and Directed Donor Egg Program, aligning with regulatory guidelines for Human Cells, and Cellular and Tissue-Based Products (HCT/Ps). The firm is registered with the FDA for processing, storing, and distributing oocytes, semen, and embryos, and is also licensed by the NYSDOH. While a previous inspection in 2008 had noted a verbal observation regarding a past failure to register with the FDA for 2007 and 2008, this issue was no longer a concern. During the current inspection, no deficiencies were identified, and the firm's written procedures were found to be current and compliant. As a result, no FDA Form 483, which lists inspectional observations, was issued. The final regulatory decision for this inspection was "No Action Indicated," meaning no further actions were required from the FDA.