FDA 483 - Medwest Associates - August 27, 2025
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Lightbody Medical Technologies Inc dba Artemis Surgical, an HCT/P distributor in Burr Ridge, IL, was cited for failing to properly evaluate incoming human cells, tissues, and cellular and tissue-based products (HCT/Ps) for microorganisms, damage, and contamination. The firm also failed to document verification activities for product acceptance, rejection, or quarantine, and did not review or document that release criteria were met before distributing HCT/Ps. These failures indicate significant deficiencies in quality control and record-keeping for distributed HCT/Ps.
ID · 791daad9-6fcc-46e1-bbd2-f33b3fe8e515