FDA 483 - MRT BIO Inc - December 13, 2024

An FDA inspection of MRT BIO Inc, an HCT/P establishment in La Palma, CA, revealed two significant observations. The firm failed to monitor and document storage temperatures for HCT/Ps and lacked documented and followed procedures for the receipt, shipment, and distribution of these products. These issues indicate a lack of control over critical processes for human cells, tissues, and cellular and tissue-based products.