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Baxalta Belgium Manufacturing SA

FDA Regulatory Profile

Baxalta Belgium Manufacturing SA has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 1 compliance action on record.

What these totals cover: FDA records filed under the name "Baxalta Belgium Manufacturing SA" and its spelling variant "Baxalta Belgium Manufacturing".

Latest inspection: Nov 22, 2024 · 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	7	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

Baxalta Belgium Manufacturing SA'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	1	0	0	0	0
2023	0	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	1	0	0	0	0
2018	0	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

7 inspections from Oct 19, 2009 to Nov 22, 2024.

Date	Site	Product	Classification	FEI
Nov 22, 2024	Lessines, Belgium	Biologics	Voluntary Action Indicated (VAI)	3002806503
May 31, 2019	Lessines, Belgium	Biologics	Voluntary Action Indicated (VAI)	3002806503
Feb 24, 2015	Lessines, Belgium	Biologics	Voluntary Action Indicated (VAI)	3002806503
Jun 18, 2013	Lessines, Belgium	Devices	No Action Indicated (NAI)	3002806503
Mar 19, 2013	Lessines, Belgium	Biologics	Voluntary Action Indicated (VAI)	3002806503
Jan 21, 2011	Lessines, Belgium	Biologics	Official Action Indicated (OAI)	3002806503
Oct 19, 2009	Lessines, Belgium	Biologics	Official Action Indicated (OAI)	3002806503

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 Baxalta Belgium Manufacturing SA: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.

Most recent: Warning Letter, Jan 15, 2010.

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 3002806503	Lessines, Belgium	7	Nov 22, 2024

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