FDA 483 - MRT BIO Inc - December 13, 2024

MRT BIO Inc, an HCT/P establishment in La Palma, CA, was inspected by the FDA, revealing significant deficiencies in the firm's control over Human Cells, Tissues, and Cellular and Tissue-Based Products. The inspection found that the firm failed to monitor and document HCT/P storage temperatures and did not adhere to established procedures for product receipt and release. These issues indicate a lack of adequate controls over critical aspects of HCT/P handling.