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Janssen Biologics B.V.

FDA Regulatory Profile

Janssen Biologics B.V. has 0 FDA recalls, 7 inspections, 0 510(k) clearances and 0 compliance actions on record.

What these totals cover: FDA records filed under the name "Janssen Biologics B.V." and its spelling variant "Janssen Biologics".

Latest inspection: Jun 1, 2023 · 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 13, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Janssen Biologics B.V.'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	1	0	0	0	0
2022	0	0	0	0	0
2021	0	0	0	0	0
2020	0	0	0	0	0
2019	0	0	0	0	0
2018	2	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 Jul 6, 2010 to Jun 1, 2023.

Date	Site	Product	Classification	FEI
Jun 1, 2023	Leiden, Netherlands	Drugs	Voluntary Action Indicated (VAI)	3002806632
Oct 11, 2018	Leiden, Netherlands	Drugs	Voluntary Action Indicated (VAI)	3002806632
Jun 15, 2018	Leiden, Netherlands	Drugs	No Action Indicated (NAI)	3002806632
May 27, 2016	Leiden, Netherlands	Drugs	No Action Indicated (NAI)	3002806632
Jul 11, 2014	Leiden, Netherlands	Drugs	Voluntary Action Indicated (VAI)	3002806632
Sep 28, 2012	Leiden, Netherlands	Drugs	Voluntary Action Indicated (VAI)	3002806632
Jul 6, 2010	Leiden, Netherlands	Drugs	No Action Indicated (NAI)	3002806632

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 3002806632	Leiden, Netherlands	7	Jun 1, 2023

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