Purpose: An ongoing investigation has uncovered significant violations of FDA regulations and determined that the New York Fertility Institute does not have adequate protections in place against the risks of communicable disease transmission
The U.S. Food and Drug Administration’s (FDA) investigation of the New York Fertility Institute located in New York, New York, a human cell, tissue and cellular and tissue-based product (HCT/P) establishment that performs donor screening, is responsible for donor testing, and determines the eligibility of anonymous and directed donors of reproductive HCT/Ps (oocytes and semen), as well as other activities such as storage, uncovered significant violations of FDA’s HCT/P regulations. FDA has identified significant deviations from the requirements regarding donor screening and testing, and has determined that because the New York Fertility Institute is in violation of 21 CFR Part 1271, the establishment does not provide adequate protections against the risks of communicable disease transmission through the use of the HCT/Ps and has determined that there are reasonable grounds to believe that these violative HCT/Ps pose a danger to health.
As a result of the deviations from FDA regulations, on March 1, 2013, FDA issued an Order to Cease Manufacturing of HCT/Ps to Majid Fateh, M.D., in his personal capacity, as well as in his capacity as Medical Director of the New York Fertility Institute, and to the New York Fertility Institute. The Order requires the following actions with regard to HCT/Ps from anonymous and directed donors:
- the immediate cessation of all manufacturing of HCT/Ps from directed or anonymous donors until compliance with the regulations in 21 CFR 1271 has been achieved and FDA provides written authorization to resume such operations; and
- the continued storage of all HCT/Ps recovered on or after May 25, 2005, which are in the establishment’s possession.
Additionally, the Order requests that the establishment immediately notify, by copy of the Order, all persons that were recipients of HCT/Ps subject to the Order, who have offspring as the result of an Assisted Reproductive Technology cycle that involved HCT/Ps subject to the Order, or who have such HCT/Ps in storage. Note that HCT/Ps obtained from sexually intimate partners do not require donor screening and testing, and are not subject to the Order or notification request.
Specifically, FDA’s investigation noted significant non-compliance with the federal regulations pertaining to HCT/P donor eligibility requirements including, but not limited to:
- Failure to determine as ineligible a donor whose specimen tests reactive on a screening test for a communicable disease agent.
- Failure to use appropriate FDA-licensed, approved, or cleared screening tests to test specimens from anonymous or directed donors for evidence of infection due to relevant communicable disease agents.
- Failure to test specimens from anonymous or directed donors to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents of the genitourinary tract.
- Failure to determine as ineligible a donor who is identified as having a risk factor for, or clinical evidence of, any of the relevant communicable disease agents or diseases for which screening is required.
- Failure to determine whether a donor is eligible based upon the results of donor screening and testing.
- Failure to collect donor specimens for testing for relevant communicable diseases at the time of recovery of the reproductive cells or tissue; or for oocyte donors, within 30 days prior to oocyte recovery or up to seven days after recovery.
- Failure to maintain records that are accurate, indelible, and legible.
- Failure to screen donors of reproductive cells or tissue by reviewing the donor's relevant medical records for risk factors for, and clinical evidence of, relevant communicable disease agents and diseases.
- Failure to establish and maintain procedures for all steps performed in testing, screening and determining donor eligibility.
Based on the inspectional findings, FDA believes that adequate steps have not been taken to prevent the introduction, transmission, or spread of communicable disease during donor screening and testing of anonymous and directed reproductive HCT/P donors. With appropriate donor screening and testing, the overall risk of communicable disease transmission from donors of reproductive tissues to recipients through Assisted Reproductive Technology procedures is low. The actions of the New York Fertility Institute regarding screening and testing of anonymous and directed donors increase the risk of communicable disease transmission, posing a danger to the health of the recipients.
- FDA recommends that recipients of tissue from anonymous and directed donations discuss with their primary care provider what testing for communicable disease agents may be appropriate.
- Clients who, at the time of receipt of this Order, are currently undergoing hormonal stimulation for recovery or implantation of reproductive tissues should discuss their options regarding upcoming procedures with Dr. Fateh.
- Review the Order to Cease Manufacturing issued to the New York Fertility Institute for information on the nature of the establishment’s violations.
- Discuss with patients who received reproductive tissue from this establishment since March 25, 2005, what communicable disease testing may be appropriate.
- Order to Cease Manufacturing
- Tissue & Tissue Products
- FDA requirements for screening and testing of reproductive donors
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