FDA 483 - Medwest Associates - August 27, 2025
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An FDA inspection of Lightbody Medical Technologies Inc dba Artemis Surgical, an HCT/P Distributor in Burr Ridge, IL, revealed a significant failure to evaluate incoming Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) for microorganisms, damage, and contamination. The firm also failed to document critical activities related to product acceptance, rejection, quarantine, and release criteria before distributing HCT/Ps, which included human amniotic, membrane, bone, cartilage, ligament, skin, tendon, and umbilical cord tissue.
ID · 49c29cf3-7bbb-4e9e-8909-44adea80c47f