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Novo Nordisk Production Belgium SA FDA Record

Warning letters, Form 483s, inspections, recalls and 510(k) clearances

Latest inspection VAI · Apr 7, 2023
No warning letters matched by name

Inspections 12

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Novo Nordisk Production Belgium SA has 0 FDA recalls, 12 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Novo Nordisk Production Belgium SA" is on file.

What these totals cover: FDA records filed under the name "Novo Nordisk Production Belgium SA" and its spelling variant "Novo Nordisk Production Belgium".

Latest inspection: Apr 7, 2023 · VAI

Summary

Record counts and when each FDA source was last refreshed
Records	Count	Last refreshed	Source as of	Status
Recalls	0	Nov 11, 2026 (checked Nov 15, 2026, unchanged)	File dated Nov 10, 2026	Current
510(k) clearances	0	Nov 15, 2026	File dated Nov 9, 2026	Current
Inspections	12	Nov 15, 2026	Newest record Nov 5, 2026	Current
Compliance actions	0	Nov 2, 2026	Newest record Oct 29, 2026	Current

FDA record by year

Novo Nordisk Production Belgium SA's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Novo Nordisk Production Belgium SA: FDA inspections per year

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	1	0	0	0	0
2021	0	0	0	0	0
2020	1	0	0	0	0
2019	1	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.

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Recent FDA inspections

12 inspections from Jul 20, 2009 to Apr 7, 2023.

Date	Site	Product	Classification	FEI
Apr 7, 2023	Brussels, Belgium	Drugs	Voluntary Action Indicated (VAI)	3007647000
Aug 19, 2022	Brussels, Belgium	Drugs	Voluntary Action Indicated (VAI)	3007647000
Jan 22, 2020	Brussels, Belgium	Drugs	Voluntary Action Indicated (VAI)	3007647000
Jun 19, 2019	Brussels, Belgium	Biologics	Voluntary Action Indicated (VAI)	3007647000
Jul 31, 2018	Brussels, Belgium	Devices	No Action Indicated (NAI)	3007647000
Jul 7, 2017	Brussels, Belgium	Biologics	Voluntary Action Indicated (VAI)	3007647000
Nov 25, 2016	Brussels, Belgium	Veterinary	No Action Indicated (NAI)	3007647000
May 28, 2015	Brussels, Belgium	Biologics	Voluntary Action Indicated (VAI)	3007647000
Feb 13, 2015	Brussels, Belgium	Drugs	Voluntary Action Indicated (VAI)	3007647000
Jan 30, 2013	Brussels, Belgium	Drugs	Voluntary Action Indicated (VAI)	3007647000
Jun 10, 2011	Brussels, Belgium	Biologics	Voluntary Action Indicated (VAI)	3007647000
Jul 20, 2009	Brussels, Belgium	Biologics	Voluntary Action Indicated (VAI)	3007647000

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 3007647000	Brussels, Belgium	12	Apr 7, 2023

Novo Nordisk Production Belgium SA and the FDA: common questions

Has Novo Nordisk Production Belgium SA received an FDA warning letter?

No FDA warning letter addressed to the name "Novo Nordisk Production Belgium SA" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.

Has Novo Nordisk Production Belgium SA received an FDA Form 483?

FDA has not published a Form 483 for "Novo Nordisk Production Belgium SA" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Novo Nordisk Production Belgium SA?

The most recent FDA inspection on file ended Apr 7, 2023 at Brussels, Belgium and was classified VAI. FDA has 12 inspections of Novo Nordisk Production Belgium SA on file.

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