FDA orders Puerto Rico fertility clinic to cease manufacturing immediately for significant violations that pose a danger to health

https://www.fda.gov/news-events/press-announcements/fda-orders-puerto-rico-fertility-clinic-cease-manufacturing-immediately-significant-violations-pose?utm_campaign=112719_PR_FDA%20orders%20Puerto%20Rico%20fertility%20clinic%20to%20cease%20manufacturing%20immediately&utm_medium=email&utm_source=Eloqua

FDA orders Puerto Rico fertility clinic to cease manufacturing immediately for significant violations that pose a danger to health

Clinic had significant donor eligibility violations, including donor screening and testing

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. “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 ...

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