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On November 20, 2019, the U.S. Food and Drug Administration sent a warning letter to RichSource Stem Cells, Inc. The warning letter outlines a review conducted by the Office of Compliance and Biologics Quality in the Center for Biologics Evaluation and Research, noting that RICHGEN appears to be a human cell, tissue, or cellular or tissue-based product currently not meeting the criteria outlined in 21 CFR 1271.15 . . .
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