# FDA 483 - MRIGlobal - August 29, 2022

Source: https://www.globalkeysolutions.net/records/483/mriglobal/a33e5640-e979-4ead-8a71-08e85a43f037

> FDA 483 for MRIGlobal on August 29, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: MRIGlobal
- Inspection Date: 2022-08-29
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: MRIGlobal, a contract laboratory in Kansas City, MO, was cited for significant deficiencies in its quality system related to investigations. The firm failed to consistently document conclusions, identify root causes, or implement follow-up corrective actions for unexplained discrepancies, resulting in a backlog of open quality reports and CAPAs. This indicates a systemic issue with their investigation and corrective action processes.

## Related Officers

- [Torrey M. Ward](https://www.globalkeysolutions.net/people/torrey-m-ward/e3021951-811e-45a0-a029-69c7cc862fcf)
- [Gretchen L. Trendel](https://www.globalkeysolutions.net/people/gretchen-l-trendel/4de8009a-85c5-4a1c-a6c8-53b110b19bee)

Company: https://www.globalkeysolutions.net/companies/mriglobal/52b432ff-e4bd-4ce2-80b5-30d4f35e5015

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8