Sigma-Aldrich Manufacturing LLC
Form 483 issued April 28, 2025 · Saint Louis, Missouri
- Inspection
- Apr 21 – Apr 28, 2025
- Investigators
- Mary L. Schuckmann· Robert J. Ham· Scott D. McGrew
- Observations
- 4
- Pages
- 5
- FEI number
- 1937990
In short: On April 28, 2025, FDA issued a Form 483 with 4 observations to Sigma-Aldrich Manufacturing LLC in Saint Louis, Missouri (FEI 1937990) after an inspection that ran Apr 21 – Apr 28, 2025. The investigators were Mary L. Schuckmann, Robert J. Ham and Scott D. McGrew. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Manufacturing deviations have not…
- 02
Appropriate specifications should be established for APIs in accordance with accepted standards and consistent…
- 03
Computerized systems should have sufficient controls to prevent unauthorized access…
- 04
Written validation protocol does not establish how validation of a particular…
This inspection in context
Mary L. Schuckmann
2 documents · 2024–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Illinois.
The firmSigma-Aldrich Manufacturing LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sigma-Aldrich Manufacturing LLC?
FDA listed 4 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Sigma-Aldrich Manufacturing LLC?
Mary L. Schuckmann, Robert J. Ham and Scott D. McGrew are named on this Form 483, for the inspection of Apr 21 – Apr 28, 2025. Each investigator has a profile showing what they cite most.
When was Sigma-Aldrich Manufacturing LLC inspected by FDA?
The inspection ran Apr 21 – Apr 28, 2025, and the Form 483 is dated April 28, 2025.
How do I get the full Form 483 for Sigma-Aldrich Manufacturing LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.