# FDA 483 - Sigma-Aldrich Manufacturing LLC - February 06, 2019

Source: https://www.keypedia.com/records/483/sigma-aldrich-manufacturing-llc/511029c3-bc04-4c87-be9a-a8abb637afc2

> FDA 483 for Sigma-Aldrich Manufacturing LLC on February 06, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sigma-Aldrich Manufacturing LLC
- Inspection Date: 2019-02-06
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Sigma Aldrich Manufacturing, LLC in Saint Louis, MO, an API manufacturer, was cited for significant quality system deficiencies. Observations included failures in investigating out-of-specification results and critical deviations, including falsified batch records and delayed customer reporting. Additionally, the firm failed to adequately investigate product complaints related to incompatible containers and lacked timely complaint investigation procedures.

## Related Documents

- [483 - 2020-01-31](https://www.keypedia.com/records/483/sigma-aldrich-manufacturing-llc/408e85ec-3a31-42cb-879e-02d755a64055)

## Related Officers

- [investigator](https://www.keypedia.com/people/ana-paula-p-sandee/7c96feb2-cb1d-4808-a65c-eafba38c3b2d)
- [Investigator?](https://www.keypedia.com/people/robert-j-ham/9146e819-4fce-420c-a722-cbe14e3c6afb)

Company: https://www.keypedia.com/companies/sigma-aldrich-manufacturing-llc/e6637246-5655-4a30-849d-a25e3a5cd06c

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