483
MRT BIO IncFDA 483 - MRT BIO Inc - December 13, 2024
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Record Details
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.
- Person
Open in Dashboard
ID · e43ca7f8-e93c-4c56-bcf1-60ea81a36519