# FDA 483 - Sigma-Aldrich Manufacturing LLC - January 31, 2020

Source: https://www.keypedia.com/records/483/sigma-aldrich-manufacturing-llc/408e85ec-3a31-42cb-879e-02d755a64055

> FDA 483 for Sigma-Aldrich Manufacturing LLC on January 31, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sigma-Aldrich Manufacturing LLC
- Inspection Date: 2020-01-31
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: This FDA Form 483 issued to Sigma-Aldrich Manufacturing LLC in Saint Louis, MO, details significant deficiencies in manufacturing process control, quality systems, and data integrity for drug substance production. Observations include repeated equipment failures with inadequate investigations, environmental monitoring shortcomings, and a lack of validated cleaning, equipment, and data acquisition systems. The findings indicate a need for comprehensive improvements in quality assurance and control.

## Related Documents

- [483 - 2019-02-06](https://www.keypedia.com/records/483/sigma-aldrich-manufacturing-llc/511029c3-bc04-4c87-be9a-a8abb637afc2)

## Related Officers

- [William Hallett, Ph.D., Lead Chemist](https://www.keypedia.com/people/william-hallett-phd-lead-chemist/561e7985-231f-46ab-8c24-5f062c38247b)
- [Suhong Li, Ph.D., Chemist](https://www.keypedia.com/people/suhong-li-phd-chemist/668c07ca-7653-4e9c-b3c4-65cec9846781)
- [Chih-Jung Hsu, Ph.D., Staff Fellow](https://www.keypedia.com/people/chih-jung-hsu-phd-staff-fellow/986d155a-d64e-494b-a338-7bf4e244e4b7)

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

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd