30/11/2019
Regulatory focus news letter
FDA orders Puerto Rico fertility clinic to cease manufacturing immediately for significant violations that pose a danger to health
Clinic had significant donor eligibility
The U.S. Food and Drug Administration has e of San Juan, Puerto Rico and its Medical Director and Owner, Dr. Rosa I. Cruz, to immediately cease manufacturing due to significant violations of FDA regulations. An FDA inspection and subsequent record review revealed significant violations of regulations regarding donor eligibility determinations, including donor screening and testing. The clinic’s failure to fulfill these requirements puts patients at risk for exposure to communicable diseases, including HIV and hepatitis.
“Patients use fertility clinics to help them become parents and they rely on these clinics to follow the appropriate regulatory requirements for screening and testing of donors of reproductive tissue. Patients should not have to worry about being at risk or becoming infected with a communicable disease when receiving reproductive tissues. In this case, the clinic’s actions put patients at risk and violated the FDA’s regulations, and we took this action to stop these potentially harmful practices,” said Peter Marks, M.D., Ph.D., Director of the FDA’s Center for Biologics Evaluation and Research. “We will use the full scope of our authorities to take action, as appropriate, to protect the public from those who choose to disregard the rules and potentially cause harm.”
The FDA issued this order upon finding that the establishment is in violation of FDA regulations that require certain protections to prevent the introduction, transmission, and spread of communicable diseases by human cells, tissues, or cellular or tissue-based products (HCT/Ps). The FDA has also determined that there are reasonable grounds to believe that the HCT/Ps manufactured by the establishment pose a danger to health.
The FDA’s inspection of the Gynecology, Reproductive Endocrinology and Fertility Institute from August 26 to October 1 revealed that, among other violations, the clinic failed to test specimens from anonymous or directed donors of reproductive cells or tissue for relevant communicable disease agents—including HIV-1/2, hepatitis B virus, hepatitis C virus, syphilis, gonorrhea and chlamydia—using appropriate FDA-licensed, approved or cleared donor screening tests. Additionally, the clinic failed to determine donor eligibility, based on the results of donor screening and donor testing, prior to implantation, transplantation, infusion, or transfer of HCT/Ps. The clinic also failed to determine as ineligible donors who were 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. Under the FDA’s regulations, the clinic is responsible for following all applicable requirements designed to prevent the introduction, transmission or spread of communicable diseases. The Gynecology, Reproductive Endocrinology and Fertility Institute clinic did not follow those requirements.
Per the order issued by the agency, the clinic must immediately cease all manufacturing of HCT/Ps from directed or anonymous reproductive tissue donors, which includes any or all steps in the recovery, processing, storage, labeling, packaging, or distribution of any human cell or tissue, and the screening or testing of cell or tissue donors. The order further requires the clinic to continue to store all HCT/Ps subject to the order, which are in their possession, or received after the date of the order. The clinic cannot resume operations until it achieves compliance with the regulations in 21 CFR Part 1271 and receives written authorization from the FDA to resume operations. Additionally, the FDA has asked the clinic to immediately notify regarding the order any patients of the clinic since May 25, 2005, who were recipients of anonymous or directed donations of reproductive tissues (such as gestational carriers or surrogates); have offspring as the result of an assisted reproductive technology cycle with the clinic, involving an anonymous or directed reproductive tissue donor; or have stored tissues that involve anonymous or directed reproductive tissue donors. Patients of this clinic who have concerns should reach out to the clinic or their health care professional with questions about testing for any communicable disease. However, at this time, the FDA is not aware of any reports of transmission of communicable diseases from patients at this clinic.
The FDA’s order to cease manufacturing HCT/Ps went in effect immediately upon being issued on November 25, although the agency has offered the clinic the opportunity for a regulatory hearing. The clinic has five days to request the hearing.
