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Lundbeck Pharmaceuticals Italy S.P.A. FDA Record

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

Lundbeck Pharmaceuticals Italy S.P.A. has 0 FDA recalls, 5 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Lundbeck Pharmaceuticals Italy S.P.A." is on file.

What these totals cover: FDA records filed under the name "Lundbeck Pharmaceuticals Italy S.P.A." and its spelling variant "Lundbeck Pharmaceuticals Italy".

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	5	Nov 14, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Lundbeck Pharmaceuticals Italy S.P.A.'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	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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Recent FDA inspections

5 inspections from Mar 13, 2009 to Mar 25, 2022.

Date	Site	Product	Classification	FEI
Mar 25, 2022	Padova, Italy	Drugs	Voluntary Action Indicated (VAI)	3002808449
May 12, 2017	Padova, Italy	Drugs	Voluntary Action Indicated (VAI)	3002808449
Apr 17, 2015	Padova, Italy	Drugs	No Action Indicated (NAI)	3002808449
Sep 28, 2012	Padova, Italy	Drugs	No Action Indicated (NAI)	3002808449
Mar 13, 2009	Padova, Italy	Drugs	No Action Indicated (NAI)	3002808449

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

1 inspected site, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3002808449	Padova, Italy	5	Mar 25, 2022

Lundbeck Pharmaceuticals Italy S.P.A. and the FDA: common questions

Has Lundbeck Pharmaceuticals Italy S.P.A. received an FDA warning letter?

No FDA warning letter addressed to the name "Lundbeck Pharmaceuticals Italy S.P.A." 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 Lundbeck Pharmaceuticals Italy S.P.A. received an FDA Form 483?

FDA has not published a Form 483 for "Lundbeck Pharmaceuticals Italy S.P.A." in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Lundbeck Pharmaceuticals Italy S.P.A.?

The most recent FDA inspection on file ended Mar 25, 2022 at Padova, Italy and was classified VAI. FDA has 5 inspections of Lundbeck Pharmaceuticals Italy S.P.A. on file.

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