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H. Lundbeck A/S

FDA Regulatory Profile

H. Lundbeck A/S has 0 FDA recalls, 9 inspections, 0 510(k) clearances and 0 compliance actions on record.

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

Latest inspection: Dec 16, 2022 · VAI

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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	9	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

H. Lundbeck A/S'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	2	0	0	0	0
2021	0	0	0	0	0
2020	1	0	0	0	0
2019	0	0	0	0	0
2018	1	0	0	0	0
2017	0	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.

Recent FDA inspections

9 inspections from May 8, 2009 to Dec 16, 2022.

Date	Site	Product	Classification	FEI
Dec 16, 2022	Valby, Denmark	Drugs	Voluntary Action Indicated (VAI)	3002807185
Nov 16, 2022	Nykobing Sj, Denmark	Drugs	Voluntary Action Indicated (VAI)	3002807184
Jul 1, 2020	Nykobing Sj, Denmark	Drugs	Voluntary Action Indicated (VAI)	3002807184
Apr 27, 2018	Valby, Denmark	Drugs	Voluntary Action Indicated (VAI)	3002807185
May 13, 2016	Nykobing Sj, Denmark	Drugs	No Action Indicated (NAI)	3002807184
May 6, 2016	Valby, Denmark	Drugs	No Action Indicated (NAI)	3002807185
Jun 17, 2013	Nykobing Sj, Denmark	Drugs	No Action Indicated (NAI)	3002807184
Jun 10, 2013	Valby, Denmark	Drugs	No Action Indicated (NAI)	3002807185
May 8, 2009	Valby, Denmark	Drugs	Voluntary Action Indicated (VAI)	3002807185

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 3002807185	Valby, Denmark	5	Dec 16, 2022
FEI 3002807184	Nykobing Sj, Denmark	4	Nov 16, 2022

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