# FDA 483 - Solventum US LLC - September 06, 2024

Source: https://www.globalkeysolutions.net/records/483/solventum-us-llc/d6db10f1-99fd-4747-9d6c-5b05c7f367a4

> FDA 483 for Solventum US LLC on September 06, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Solventum US LLC
- Inspection Date: 2024-09-06
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Solventum US LLC in Columbia, MO, a manufacturer of drug products, was cited with two observations during an FDA inspection. The firm's stability program for drug products lacked reliable test methods for degradation impurities. Additionally, the inspection found inadequate controls over computer systems, with multiple production personnel sharing a single login account for critical equipment.

## Related Officers

- [Investigator](https://www.globalkeysolutions.net/people/jacob-g-lutz/ca2710c6-064f-4728-9129-aad73e74f12d)
- [investigator](https://www.globalkeysolutions.net/people/geoffrey-k-kilili/b00aeedf-95bd-4ccf-a23e-6e12e60249c4)

Company: https://www.globalkeysolutions.net/companies/solventum-us-llc/ca1da2f8-9b30-43dd-bb33-05c707a43932

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