FDA EIR - IVF New York - September 06, 2012

An FDA inspection of IVF New York, located in New York City, was conducted on September 6, 2012. The inspection, part of the agency's annual workplan, aimed to assess the facility's compliance as an establishment handling reproductive human tissue.The inspection revealed that IVF New York had discontinued its In Vitro Fertilization (IVF) program in January 2012 and no longer performs egg retrievals or embryo transfers. The facility, however, maintains its license from the New York State Department of Health as a Tissue Bank and continues to store frozen embryos and sperm. A review of records covering handled tissues found no deficiencies, leading to an overall "No Action Indicated" conclusion for this inspection.A notable situation identified was that a significant number of clients have stopped paying storage fees and effectively abandoned their reproductive tissues. The firm indicated that these tissues cannot be legally destroyed without explicit written authorization from the owners and the NYSDH. Efforts to contact these clients have been hindered by a lack of current contact information.The primary action required of IVF New York is to update its FDA establishment registration. This update is necessary to accurately reflect its current operational status as solely a storage facility for reproductive tissues, rather than an active reproductive tissue program. The inspection confirmed the firm's transition and its ongoing efforts regarding the disposition of abandoned tissues.