Sigma-Aldrich Manufacturing LLC
FDA inspection history in Saint Louis, Missouri, 2019 to 2025
- 3
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2020: one Form 483; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–20Two Form 483s, at Saint Louis, Missouri.
- 2020The longest 483 on file: 9 observations over 5 pages at Saint Louis, Missouri.
- 2025One Form 483, at Saint Louis, Missouri.
Cited most
Across all Sigma-Aldrich Manufacturing observations on file
- 21 CFR 211.160General requirements3
- 21 CFR 211.192Production record review3
- 21 CFR 211.68Automatic, mechanical, and electronic equipment3
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
The complete Sigma-Aldrich Manufacturing file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Saint Louis, Missouri
Three Form 483s · 2019 to 2025 · 15 observations
Latest: Form 483, Apr 28, 2025 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-04-28 | 483 Form 483 | Saint Louis, Missouri | 4 | $99 |
| 2020-01-31 | 483 Form 483 | Saint Louis, Missouri | 9 | $99 |
| 2019-02-06 | 483 Form 483 | Saint Louis, Missouri | 2 | $99 |
Investigators on these documents
Robert J. Ham (2)Chih-Jung Hsu (1)Mary L. Schuckmann (1)Ana P. Sandee (1)Scott D. McGrew (1)William Hallett (1)Zhong Li (1)
FEI number 1937990 · most recent document Apr 28, 2025
About Sigma-Aldrich Manufacturing LLC
How many FDA Form 483s has Sigma-Aldrich Manufacturing LLC received?
FDA Intel has 3 Form 483s on file for Sigma-Aldrich Manufacturing LLC; the most recent is dated Apr 28, 2025.
When was Sigma-Aldrich Manufacturing LLC last inspected by FDA?
The most recent FDA inspection document on file for Sigma-Aldrich Manufacturing LLC is a Form 483 dated Apr 28, 2025, for the site in Saint Louis, Missouri.
What did FDA cite at Sigma-Aldrich Manufacturing LLC?
The regulations cited most in the observations on file for Sigma-Aldrich Manufacturing LLC are 21 CFR 211.160 (General requirements), 3 times; 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 3 times.