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Novo Nordisk A/S - Hax FDA Record

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

Latest inspection VAI · Jun 1, 2023
No warning letters matched by name

Inspections 10

0 OAI

Recalls 0 0 Class I

Warning letters 0 None on file

510(k) clearances 0 None on file

Novo Nordisk A/S - Hax has 0 FDA recalls, 10 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Novo Nordisk A/S - Hax" is on file.

What these totals cover: FDA records filed under the name "Novo Nordisk A/S - Hax".

Latest inspection: Jun 1, 2023 · VAI

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	10	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 A/S - Hax's FDA inspections, warning letters and recalls in each of the last 10 calendar years (2017 to 2026, 2026 so far).

Novo Nordisk A/S - Hax: 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	0	0	0	0	0
2021	0	0	0	0	0
2020	0	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.

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Recent FDA inspections

10 inspections from Mar 5, 2009 to Jun 1, 2023.

Date	Site	Product	Classification	FEI
Jun 1, 2023	Gentofte, Denmark	Drugs	Voluntary Action Indicated (VAI)	3002807748
May 8, 2018	Gentofte, Denmark	Drugs	No Action Indicated (NAI)	3002807748
Jun 14, 2016	Gentofte, Denmark	Drugs	No Action Indicated (NAI)	3002807748
Nov 6, 2015	Gentofte, Denmark	Biologics	Voluntary Action Indicated (VAI)	3002807748
May 13, 2014	Gentofte, Denmark	Drugs	Voluntary Action Indicated (VAI)	3002807748
May 1, 2013	Gentofte, Denmark	Biologics	Voluntary Action Indicated (VAI)	3002807748
Jun 26, 2012	Gentofte, Denmark	Drugs	Voluntary Action Indicated (VAI)	3002807748
Feb 17, 2011	Gentofte, Denmark	Biologics	Voluntary Action Indicated (VAI)	3002807748
Mar 6, 2009	Gentofte, Denmark	Drugs	Voluntary Action Indicated (VAI)	3002807748
Mar 5, 2009	Gentofte, Denmark	Biologics	Voluntary Action Indicated (VAI)	3002807748

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 3002807748	Gentofte, Denmark	10	Jun 1, 2023

Novo Nordisk A/S - Hax and the FDA: common questions

Has Novo Nordisk A/S - Hax received an FDA warning letter?

No FDA warning letter addressed to the name "Novo Nordisk A/S - Hax" 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 A/S - Hax received an FDA Form 483?

FDA has not published a Form 483 for "Novo Nordisk A/S - Hax" in its reading room. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Novo Nordisk A/S - Hax?

The most recent FDA inspection on file ended Jun 1, 2023 at Gentofte, Denmark and was classified VAI. FDA has 10 inspections of Novo Nordisk A/S - Hax on file.

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