The FDA recently filed two complaints in federal court seeking permanent injunctions against two stem cell clinics to stop them from marketing stem cell products without FDA approval, according to a press release.
The FDA is seeking a permanent injunction against US Stem Cell Clinic LLC of Sunrise, Florida, its chief scientific officer Kristin Comella and its co-owner and managing officer Theodore Gradel for marketing stem cell products to patients without FDA approval and violating current good manufacturing practice requirements. The clinic did not address violations in a warning letter
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