# FDA 483 - MRT BIO Inc - December 13, 2024

Source: https://www.keypedia.com/records/483/mrt-bio-inc/02f132b4-2a0f-44be-b360-a549e574ef5b

> FDA 483 for MRT BIO Inc on December 13, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MRT BIO Inc
- Inspection Date: 2024-12-13
- Product Type: biologics
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: 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.

## Related Documents

- [483 - 2024-12-13](https://www.keypedia.com/records/483/mrt-bio-inc/e43ca7f8-e93c-4c56-bcf1-60ea81a36519)

## Related Officers

- [Melsomar R. Ramos](https://www.keypedia.com/people/melsomar-r-ramos/395e7ddc-ed98-455a-a143-0ee5f46804f4)

Company: https://www.keypedia.com/companies/mrt-bio-inc/09e24707-950b-42d1-b710-e35dd022ea1b

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6