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Lonza Walkersville, Inc.

FDA Regulatory Profile

Lonza Walkersville, Inc. has 0 FDA recalls, 11 inspections, 0 510(k) clearances and 1 compliance action on record.

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

Latest inspection: Mar 24, 2026 · NAI

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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	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

Lonza Walkersville, 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
2026	1	0	0
2025	0	0	0
2024	0	0	0
2023	0	0	0
2022	0	0	0
2021	1	0	0
2020	0	0	0
2019	0	0	0
2018	2	0	0
2017	1	1	1

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

11 inspections from Oct 10, 2008 to Mar 24, 2026.

Date	Site	Product	Classification	FEI
Mar 24, 2026	Walkersville, MD	Devices	No Action Indicated (NAI)	1114298
Nov 5, 2021	Walkersville, MD	Devices	Voluntary Action Indicated (VAI)	1114298
Jul 26, 2018	Walkersville, MD	Biologics	Voluntary Action Indicated (VAI)	1114298
Jul 3, 2018	Walkersville, MD	Devices	No Action Indicated (NAI)	1114298
Feb 6, 2017	Walkersville, MD	Devices	Official Action Indicated (OAI)	1114298
Jun 9, 2016	Walkersville, MD	Biologics	Voluntary Action Indicated (VAI)	1114298
Aug 13, 2013	Walkersville, MD	Biologics	Voluntary Action Indicated (VAI)	1114298
Dec 2, 2011	Walkersville, MD	Biologics	Voluntary Action Indicated (VAI)	1114298
Aug 23, 2011	Walkersville, MD	Biologics	No Action Indicated (NAI)	1114298
Dec 17, 2009	Walkersville, MD	Biologics	No Action Indicated (NAI)	1114298
Oct 10, 2008	Walkersville, MD	Biologics	Voluntary Action Indicated (VAI)	1114298

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

Most recent: Warning Letter, Apr 21, 2017.

Individual 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 1114298	Walkersville, MD	11	Mar 24, 2026

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