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Wyeth Lederle S.R.L FDA Record

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

Latest inspection VAI · Nov 15, 2024
Last warning letter 2013

Inspections 6

2 OAI

Recalls 0 0 Class I

Warning letters 1 Latest Mar 27, 2013

510(k) clearances 0 None on file

Wyeth Lederle S.R.L has 0 FDA recalls, 6 inspections, 0 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Wyeth Lederle S.R.L, the most recent on Mar 27, 2013.

What these totals cover: FDA records filed under the name "Wyeth Lederle S.R.L" and its spelling variant "Wyeth Lederle".

Latest inspection: Nov 15, 2024 · VAI

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	6	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Wyeth Lederle S.R.L's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Wyeth Lederle S.R.L: 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	1	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	0	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.

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Wyeth Lederle S.R.L FDA Warning Letters

1 warning letter on Mar 27, 2013.

Issued	Subject	Issuing office	Close-out letter
Mar 27, 2013 · 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.

Recent FDA inspections

6 inspections from Dec 4, 2009 to Nov 15, 2024.

Date	Site	Product	Classification	FEI
Nov 15, 2024	Catania, Italy	Drugs	Voluntary Action Indicated (VAI)	3002806766
Jan 21, 2022	Catania, Italy	Drugs	Voluntary Action Indicated (VAI)	3002806766
Apr 20, 2017	Catania, Italy	Drugs	Voluntary Action Indicated (VAI)	3002806766
Nov 14, 2014	Catania, Italy	Drugs	Official Action Indicated (OAI)	3002806766
Jul 20, 2012	Catania, Italy	Drugs	Official Action Indicated (OAI)	3002806766
Dec 4, 2009	Catania, Italy	Drugs	No Action Indicated (NAI)	3002806766

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 Wyeth Lederle S.R.L: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Mar 27, 2013.

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 3002806766	Catania, Italy	6	Nov 15, 2024

Wyeth Lederle S.R.L and the FDA: common questions

Has Wyeth Lederle S.R.L received an FDA warning letter?

Yes. FDA has issued 1 warning letter to Wyeth Lederle S.R.L. The most recent is dated Mar 27, 2013.

Has Wyeth Lederle S.R.L received an FDA Form 483?

FDA has not published a Form 483 for "Wyeth Lederle S.R.L" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Wyeth Lederle S.R.L?

The most recent FDA inspection on file ended Nov 15, 2024 at Catania, Italy and was classified VAI. FDA has 6 inspections of Wyeth Lederle S.R.L on file, 2 of them classified OAI (official action indicated).

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