Sigma-Aldrich Manufacturing LLC
Form 483 issued January 31, 2020 · Saint Louis, Missouri
- Inspection
- Jan 27 – Jan 31, 2020
- Investigators
- Chih-Jung Hsu· William Hallett· Zhong Li
- Observations
- 9
- Pages
- 5
- FEI number
- 1937990
In short: On January 31, 2020, FDA issued a Form 483 with 9 observations to Sigma-Aldrich Manufacturing LLC in Saint Louis, Missouri (FEI 1937990) after an inspection that ran Jan 27 – Jan 31, 2020. The investigators were Chih-Jung Hsu, William Hallett and Zhong Li. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and laboratory controls account for 6 of 9 observations.
Most cited: 21 CFR 211.68 (2×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to…
- 02
The bulk-fill process for (6) (4) yyy) is deficient regarding the system…
- 03
Your firm lacks an established cleaning and sanitization program to prevent the introduction of contamination into…
- 04
Your firm has not established adequate procedural controls to protect the stand-alone…
This inspection in context
Chih-Jung Hsu
1 document · 2020
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Missouri.
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 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Sigma-Aldrich Manufacturing LLC?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Sigma-Aldrich Manufacturing LLC?
Chih-Jung Hsu, William Hallett and Zhong Li are named on this Form 483, for the inspection of Jan 27 – Jan 31, 2020. Each investigator has a profile showing what they cite most.
When was Sigma-Aldrich Manufacturing LLC inspected by FDA?
The inspection ran Jan 27 – Jan 31, 2020, and the Form 483 is dated January 31, 2020.
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.