Home / Companies / Sanofi-Aventis Deutschland GmbH

Sanofi-Aventis Deutschland GmbH FDA Record

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

Sanofi-Aventis Deutschland GmbH has 0 FDA recalls, 11 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Sanofi-Aventis Deutschland GmbH, the most recent on Feb 8, 2011. FDA has published 1 Form 483 for Sanofi-Aventis Deutschland GmbH.

What these totals cover: FDA records filed under the name "Sanofi-Aventis Deutschland GmbH" and its spelling variant "Sanofi-Aventis Deutschland".

Latest inspection: Mar 25, 2022 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 8, 2026	File dated Nov 3, 2026	Current
510(k) clearances	0	Nov 8, 2026	File dated Nov 2, 2026	Current
Inspections	11	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Sanofi-Aventis Deutschland GmbH's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

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	0	0	0	0	0
2022	1	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	1	0	0	0	0
2018	0	0	0	0	0
2017	1	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 Sanofi-Aventis Deutschland GmbH 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 Sanofi-Aventis Deutschland GmbH 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

Sanofi-Aventis Deutschland GmbH FDA Warning Letters

1 warning letter on Feb 8, 2011.

Issued	Subject	Issuing office	Close-out letter
Feb 8, 2011 · Record page

A warning letter is FDA's formal notice that a company has violated FDA requirements. Each date links to the letter on fda.gov where FDA has it online. Search the text of every letter with the FDA warning letter search.

Sanofi-Aventis Deutschland GmbH Form 483s

1 Form 483 published by FDA.

Date	Document	FEI
Jan 16, 2025 · Document on fda.gov	483	3003195501

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent FDA inspections

11 inspections from Oct 31, 2008 to Mar 25, 2022.

Date	Site	Product	Classification	FEI
Mar 25, 2022	Frankfurt Am Main, Germany	Drugs	Voluntary Action Indicated (VAI)	3003195501
May 14, 2019	Frankfurt Am Main, Germany	Drugs	Voluntary Action Indicated (VAI)	3003195501
Mar 3, 2017	Frankfurt Am Main, Germany	Drugs	Voluntary Action Indicated (VAI)	3003195501
Dec 10, 2015	Frankfurt Am Main, Germany	Devices	No Action Indicated (NAI)	3003195501
Jun 26, 2015	Frankfurt Am Main, Germany	Drugs	Voluntary Action Indicated (VAI)	3003195501
Dec 5, 2013	Frankfurt Am Main, Germany	Drugs	No Action Indicated (NAI)	3003195501
Jul 2, 2013	Frankfurt Am Main, Germany	Devices	Voluntary Action Indicated (VAI)	3003195501
Apr 30, 2012	Frankfurt Am Main, Germany	Drugs	No Action Indicated (NAI)	3003195501
Jul 14, 2011	Frankfurt Am Main, Germany	Drugs	Voluntary Action Indicated (VAI)	3003195501
Sep 16, 2010	Frankfurt Am Main, Germany	Drugs	Official Action Indicated (OAI)	3003195501
Oct 31, 2008	Frankfurt Am Main, Germany	Drugs	Voluntary Action Indicated (VAI)	3003195501

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.

Compliance Actions

FDA's compliance actions data lists 1 compliance action under Sanofi-Aventis Deutschland GmbH: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Feb 8, 2011.

The warning letters in this data are listed above, together with the letters FDA posts online; a letter found in both is shown once. Other actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3003195501	Frankfurt Am Main, Germany	11	Mar 25, 2022

Sanofi-Aventis Deutschland GmbH and the FDA: common questions

Has Sanofi-Aventis Deutschland GmbH received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Sanofi-Aventis Deutschland GmbH. The most recent is dated Feb 8, 2011.

Has Sanofi-Aventis Deutschland GmbH received an FDA Form 483?

FDA has published 1 Form 483 for Sanofi-Aventis Deutschland GmbH in its reading room, the most recent dated Jan 16, 2025. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Sanofi-Aventis Deutschland GmbH?

The most recent FDA inspection on file ended Mar 25, 2022 at Frankfurt Am Main, Germany and was classified VAI. FDA has 11 inspections of Sanofi-Aventis Deutschland GmbH on file, 1 of them classified OAI (official action indicated).

Need more than this page shows? Ask about Sanofi-Aventis Deutschland GmbH 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.