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

Source: https://www.globalkeysolutions.net/records/483/mrt-bio-inc/e43ca7f8-e93c-4c56-bcf1-60ea81a36519

> 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: Los Angeles District Office
- Summary: 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.

## Related Officers

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

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

Office: https://www.globalkeysolutions.net/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b