Nov 27, 2019: Due to significant violations of FDA regulations, 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 to immediately stop manufacturing that pose a danger to health.
After FDA inspection and subsequent record review, significant violations of regulations regarding donor eligibility determinations, including donor screening and testing were revealed.
The lack of requirements puts patients at risk for exposure to communicable diseases, including HIV and hepatitis.
After finding that the establishment is in violation of FDA regulations, they issued this order to to prevent the introduction, transmission, and spread of communicable diseases by human cells, tissues, or cellular or tissue-based products (HCT/Ps) manufactured by the establishment 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
