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

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.