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Lonza Biologics, Inc.

FDA Regulatory Profile

Lonza Biologics, Inc. has 0 FDA recalls, 18 inspections, 0 510(k) clearances and 1 compliance action on record.

What these totals cover: FDA records filed under the name "Lonza Biologics, Inc." and its spelling variant "Lonza Biologics".

Latest inspection: Feb 6, 2026 · 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	18	Nov 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	1	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Lonza Biologics, Inc.'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	1	0	0	0	0
2025	0	0	0	0	0
2024	1	0	0	0	0
2023	1	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	1	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.

Recent FDA inspections

18 inspections from Sep 3, 2009 to Feb 6, 2026.

Date	Site	Product	Classification	FEI
Feb 6, 2026	Portsmouth, NH	Drugs	Voluntary Action Indicated (VAI)	3001451441
Mar 7, 2024	Portsmouth, NH	Biologics	No Action Indicated (NAI)	3001451441
Jul 21, 2023	Portsmouth, NH	Drugs	Voluntary Action Indicated (VAI)	3001451441
Oct 13, 2022	Slough, United Kingdom	Drugs	Voluntary Action Indicated (VAI)	1000583959
Sep 5, 2018	Slough, United Kingdom	Drugs	Voluntary Action Indicated (VAI)	1000583959
Sep 21, 2017	Portsmouth, NH	Drugs	No Action Indicated (NAI)	3001451441
Aug 26, 2016	Portsmouth, NH	Drugs	Voluntary Action Indicated (VAI)	3001451441
Jun 24, 2016	Slough, United Kingdom	Drugs	Voluntary Action Indicated (VAI)	1000583959
Feb 10, 2015	Portsmouth, NH	Drugs	Voluntary Action Indicated (VAI)	3001451441
Sep 30, 2013	Portsmouth, NH	Drugs	Voluntary Action Indicated (VAI)	3001451441
May 2, 2013	Hopkinton, MA	Biologics	Voluntary Action Indicated (VAI)	3001701602
Sep 24, 2012	Slough, United Kingdom	Drugs	Voluntary Action Indicated (VAI)	1000583959
Sep 24, 2012	Wokingham, United Kingdom	Drugs	Voluntary Action Indicated (VAI)	3007518488
Mar 1, 2012	Hopkinton, MA	Drugs	Official Action Indicated (OAI)	3001701602
May 6, 2011	Hopkinton, MA	Drugs	Official Action Indicated (OAI)	3001701602
Apr 21, 2010	Portsmouth, NH	Drugs	Voluntary Action Indicated (VAI)	3001451441
Oct 9, 2009	Hopkinton, MA	Biologics	Voluntary Action Indicated (VAI)	3001701602
Sep 3, 2009	Portsmouth, NH	Drugs	Voluntary Action Indicated (VAI)	3001451441

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 Lonza Biologics, Inc.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Sep 1, 2011.

Individual actions are not listed on this page. Search them with the FDA warning letter search or browse all compliance actions.

FDA-inspected facilities

4 inspected sites, newest inspection first.

Facility	Location	Inspections	Latest
FEI 3001451441	Portsmouth, NH	9	Feb 6, 2026
FEI 1000583959	Slough, United Kingdom	4	Oct 13, 2022
FEI 3001701602	Hopkinton, MA	4	May 2, 2013
FEI 3007518488	Wokingham, United Kingdom	1	Sep 24, 2012

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