Market Intelligence Resource | January 6, 2020
Warning Letter: Chara Biologics, Inc.
On November 25, 2019, the U.S. Food and Drug Administration sent a warning letter to Chara Biologics, Inc. The warning letter outlines a review conducted by the Office of Compliance and Biologics Quality in the Center for Biologics Evaluation and Research stating that the firm markets the product CharaCoreâ„¢ as containing "umbilical, cord tissue, and amniotic membrane" that is "suitable for all forms of injections, to assist the body's ability to repair and regenerate." The letter further states that the product appears to be a human cell, tissue, or cellular or tissue-based product that would be subject . . .
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