# FDA 483 - Sigma-Aldrich Manufacturing LLC - April 28, 2025

Source: https://www.globalkeysolutions.net/records/483/sigma-aldrich-manufacturing-llc/21ff8057-badb-41ca-918d-7e4a2779a619

> FDA 483 for Sigma-Aldrich Manufacturing LLC on April 28, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sigma-Aldrich Manufacturing LLC
- Inspection Date: 2025-04-28
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of Sigma-Aldrich Manufacturing LLC in Saint Louis, MO, a human drug manufacturer, revealed significant deficiencies across multiple areas. The firm failed to thoroughly investigate manufacturing deviations, including repeat observations, and lacked appropriate specifications and risk assessments for nonsterile APIs. Additionally, computerized systems allowed unauthorized data alteration, and process validation activities were found to be scientifically inadequate.

## Related Officers

- [Scott D. Mcgrew](https://www.globalkeysolutions.net/people/scott-d-mcgrew/a9f36e0f-0ae6-42d1-98d2-14e324e2a7fc)
- [Investigator?](https://www.globalkeysolutions.net/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)
- [issuing_officer](https://www.globalkeysolutions.net/people/mary-l-schuckmann/fdbfffff-ef4b-49a2-8ea3-6254a600aaac)

Company: https://www.globalkeysolutions.net/companies/sigma-aldrich-manufacturing-llc/d3de3d25-e677-41db-9cb1-8e7793ce2879

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