FDA 483 - Meta Dental - June 30, 2022

An FDA inspection of Meta Dental in Northridge, CA, conducted from June 29-30, 2022, identified a significant procedural deficiency. The firm failed to establish written procedures for critical steps in the manufacture of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps), specifically regarding the receipt, storage, shipment, and distribution of human bone products. This lack of procedures led to the distribution of products without proper controls.