Atlas

FDA-Inspected Site

Sigma-Aldrich Manufacturing LLC

12 FDA inspections are on record for Sigma-Aldrich Manufacturing LLC in Saint Louis, United States.

483· Form 483 issued

Saint Louis, United States · Last updated July 10, 2026

Overview

  • 12 FDA inspections are on record.
  • 8 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-04-28.

At a glance

Inspections

12

Form 483s

8

EIRs

1

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
21 Apr 2025 – 28 Apr 2025Human Drugs483On file
27 Jan 2020 – 31 Jan 2020Human Drugs483On file
28 Jan 2019 – 6 Feb 2019Human Drugs483On file
6 Mar 2017 – 10 Mar 2017Human Drugs483On file
2 Dec 2013 – 9 Dec 2013Medical Devices & Rad Health483View 483 →
18 Jun 2012Not recorded483On file
19 Apr 2011Not recorded483On file
2 Sep 2009Not recorded483On file
10 Apr 2007Not recordedClean
10 Jan 2005Not recordedClean
1 Aug 2003Not recordedClean
7 Sep 2000Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

9 Dec 2013
21 CFR 820.40(b)

Change records, content

Cited by Eric M Padgett, Steven D Kehoe

Investigators

FDA investigators tied to this site in the record.

Robert J Ham2 insp.
Eric M Padgett2 insp.
Steven D Kehoe2 insp.
Mary L Schuckmann1 insp.
Scott D Mcgrew1 insp.
Zhong Li1 insp.
Ana Paula P Sandee1 insp.
Michele Perry-Williams1 insp.
Rita K Kabaso1 insp.
Frank Wackes1 insp.
Kshitij A Patkar1 insp.
Michele Perry Williams1 insp.
Anthony Bucks1 insp.
Hongjian Ding1 insp.
Emilio O Escobar1 insp.
Sherry G Bous1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 820.40(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Sigma-Aldrich Manufacturing LLC's 8 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat