North Louisiana Tissue BankSeptember 24, 2021

FDA 483 - North Louisiana Tissue Bank - September 24, 2021

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An FDA inspection of North Louisiana Tissue Bank in West Monroe, LA, revealed a significant deficiency in their tracking system for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). The firm failed to establish a system to track HCT/Ps to final disposition, specifically for discarded tissues. This resulted in nine discarded tissues lacking final disposition records due to unrevised and unimplemented donor procedures.

Company: North Louisiana Tissue Bank
Inspection Date: September 24, 2021
Product Type: Biologics
Office: New Orleans District Office
Person: Juanelma H. Palmer

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ID · 33936fd0-411c-4643-8e8a-a81fe4f0e91a