A fertility clinic in California has not been testing donors for sexually transmitted diseases and other viruses, prompting the Food & Drug Administration (FDA) to issue the facility a warning letter. According to the letter, the Center for Fertility and Gynecology in Tarzana, Calif., tested semen donors in laboratories using non-FDA approved screening tests.
The Center for Fertility and Gynecology claims to be the largest fertility center in the San Fernando Valley. It accepts semen from men and eggs from women, often anonymously, that can be used to get women pregnant.
The FDA warning letter followed an inspection of the facility conducted by the agency in June. The FDA investigator found significant deviations from the regulations for human cells, tissues, and cellular and tissue-based product. In several instance, the FDA said the California clinic didn’t test donors for chlamydia, a disease that can cause infertility, and gonorrhea, which can be life threatening if it spreads to the blood or joints.
The FDA cited instances in 2005, 2007 and as early as February where the clinic failed to test for the two diseases. The semen was used to fertilize eggs in women, the FDA said.
The FDA warning letter also sites several instances where the clinic did not adequately test for other virus. For example, in 2007 and 2008, the center failed to test donated semen for Human T-lymphotropic virus, types I and II and cytomegalovirus (CMV). Semen from both donors were used to fertilize embryos, and transferred to various women.
The FDA letter also cites one instance in 2006 where the fertility clinic received a positive CMV test result for a semen donor. However, the clinic had no documentation that the physician of record, donor, and surrogate were notified of the positive result. In addition, there is no documentation that the surrogate consented to proceed with the embryo transfer.
The FDA wants the clinic to respond within 15 business days to explain what steps it has taken to correct the violations and prevent future ones.
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