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Lonza Manufacturing LLC

FDA Regulatory Profile

Lonza Manufacturing LLC 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 "Lonza Manufacturing LLC" and its spelling variant "Lonza Manufacturing".

Latest inspection: Sep 29, 2025 · 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

Lonza Manufacturing LLC'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	1	0	0	0	0
2024	0	0	0	0	0
2023	0	0	0	0	0
2022	0	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 Sep 28, 2009 to Sep 29, 2025.

Date	Site	Product	Classification	FEI
Sep 29, 2025	Vacaville, CA	Drugs	Voluntary Action Indicated (VAI)	3032299571
Mar 17, 2020	Vacaville, CA	Drugs	No Action Indicated (NAI)	3032299571
Aug 22, 2018	Vacaville, CA	Drugs	Voluntary Action Indicated (VAI)	3032299571
Aug 28, 2015	Vacaville, CA	Drugs	Voluntary Action Indicated (VAI)	3032299571
Sep 19, 2014	Vacaville, CA	Drugs	No Action Indicated (NAI)	3032299571
Sep 6, 2013	Vacaville, CA	Drugs	Voluntary Action Indicated (VAI)	3032299571
Mar 28, 2012	Vacaville, CA	Drugs	Voluntary Action Indicated (VAI)	3032299571
Jun 23, 2010	Vacaville, CA	Drugs	No Action Indicated (NAI)	3032299571
Sep 28, 2009	Vacaville, CA	Drugs	Voluntary Action Indicated (VAI)	3032299571

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 3032299571	Vacaville, CA	9	Sep 29, 2025

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