FDA 483 - Meta Dental - June 30, 2022
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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.
ID · 4854ca63-0d22-4232-bb37-9f3ef9e2147d