Home / Companies / Sigma-Aldrich Mfg LLC

Sigma-Aldrich Mfg LLC FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Latest inspection NAI · Mar 23, 2023
No warning letters matched by name

Inspections 11

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Sigma-Aldrich Mfg LLC has 0 FDA recalls, 11 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Sigma-Aldrich Mfg LLC" is on file.

What these totals cover: FDA records filed under the name "Sigma-Aldrich Mfg LLC" and its spelling variant "Sigma-Aldrich Mfg".

Latest inspection: Mar 23, 2023 · NAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 11, 2026 (checked Nov 15, 2026, unchanged)	File dated Nov 10, 2026	Current
510(k) clearances	0	Nov 15, 2026	File dated Nov 9, 2026	Current
Inspections	11	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Sigma-Aldrich Mfg LLC's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Sigma-Aldrich Mfg LLC: FDA inspections per year

Year	Inspections	OAI	Warning letters	Recall records	Class I
2026	0	0	0	0	0
2025	0	0	0	0	0
2024	0	0	0	0	0
2023	1	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	1	0	0	0	0
2019	0	0	0	0	0
2018	0	0	0	0	0
2017	2	0	0	0	0

Inspections are counted by the date they ended, warning letters by the date FDA issued them and recall records by the recall start date. FDA lists one recall record per recalled product, so one recall event can add several.

Reviewing Sigma-Aldrich Mfg LLC as a supplier? Request a free FDA snapshot: name up to five suppliers and get a PDF of their public FDA record, with sources and dates. You do not need an API connection. Each snapshot is prepared by hand.

Check this supplier

Or check Sigma-Aldrich Mfg LLC yourself in Claude, Cursor or ChatGPT: get the full FDA risk summary, with inspections, warning letters, Form 483s and import alerts by site.

Get a free API key

Recent FDA inspections

11 inspections from Sep 2, 2009 to Mar 23, 2023.

Date	Site	Product	Classification	FEI
Mar 23, 2023	Saint Louis, MO	Devices	No Action Indicated (NAI)	1938173
Mar 4, 2020	Saint Louis, MO	Devices	Voluntary Action Indicated (VAI)	1938173
May 16, 2017	Saint Louis, MO	Devices	No Action Indicated (NAI)	1938173
Mar 17, 2017	Saint Louis, MO	Drugs	Voluntary Action Indicated (VAI)	1937991
Dec 9, 2013	Saint Louis, MO	Drugs	No Action Indicated (NAI)	1937991
Jun 18, 2012	Saint Louis, MO	Drugs	Voluntary Action Indicated (VAI)	1937991
Jun 15, 2012	Saint Louis, MO	Devices	Voluntary Action Indicated (VAI)	1938173
Apr 25, 2011	Saint Louis, MO	Devices	Voluntary Action Indicated (VAI)	1938173
Apr 7, 2011	Saint Louis, MO	Drugs	No Action Indicated (NAI)	1937991
Sep 2, 2009	Saint Louis, MO	Devices	Voluntary Action Indicated (VAI)	1938173
Sep 2, 2009	Saint Louis, MO	Devices	Voluntary Action Indicated (VAI)	1937991

NAI: No objectionable conditions or practices were found during the inspection.
VAI: Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
OAI: Regulatory and/or administrative actions are recommended.

Look up the inspector observations behind these results with the FDA 483 search, or check for formal enforcement with the FDA warning letter search.

FDA-inspected facilities

2 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 1938173	Saint Louis, MO	6	Mar 23, 2023
FEI 1937991	Saint Louis, MO	5	Mar 17, 2017

Sigma-Aldrich Mfg LLC and the FDA: common questions

Has Sigma-Aldrich Mfg LLC received an FDA warning letter?

No FDA warning letter addressed to the name "Sigma-Aldrich Mfg LLC" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Sigma-Aldrich Mfg LLC received an FDA Form 483?

FDA has not published a Form 483 for "Sigma-Aldrich Mfg LLC" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Sigma-Aldrich Mfg LLC?

The most recent FDA inspection on file ended Mar 23, 2023 at Saint Louis, MO and was classified NAI. FDA has 11 inspections of Sigma-Aldrich Mfg LLC on file.

Need more than this page shows? Ask about Sigma-Aldrich Mfg LLC in Claude or ChatGPT and get every site's inspections, Form 483s, warning letters and import alerts, with a link to the FDA source for each record. The API key is free: no card.