483
SigmaGraft IncFDA 483 - SigmaGraft Inc - April 25, 2025
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Record Details
SigmaGraft Inc. in Fullerton, CA, an HCT/P establishment, was cited for a significant deficiency during an FDA inspection. The firm failed to establish and maintain procedures, including release criteria, for the distribution of human bone tissue products. This lapse resulted in the distribution of numerous units without a proper Standardized Operating Procedure.
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ID · c828b71b-8e8b-458b-a466-a63b77e0f11c