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The U.S. Food and Drug Administration has ordered Gynecology, Reproductive Endocrinology and Fertility Institute 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.
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.
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.
