Novo Nordisk Pharmaceutical Industries LP FDA Record

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

  • Latest inspection NAI · Jun 30, 2026
  • No warning letters matched by name
Inspections 13 0 OAI
Recalls 0 0 Class I
Warning letters 0 None on file
510(k) clearances 0 None on file

Novo Nordisk Pharmaceutical Industries LP has 0 FDA recalls, 13 inspections, 0 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Novo Nordisk Pharmaceutical Industries LP" is on file. FDA has published 1 Form 483 for Novo Nordisk Pharmaceutical Industries LP.

What these totals cover: FDA records filed under the name "Novo Nordisk Pharmaceutical Industries LP" and its spelling variant "Novo Nordisk Pharmaceutical Industries".

Latest inspection
Jun 30, 2026 · NAI

Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Nov 8, 2026File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections13Nov 15, 2026Newest record Nov 5, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

FDA record by year

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

Novo Nordisk Pharmaceutical Industries LP: FDA inspections per year

YearInspectionsOAIWarning lettersRecall recordsClass I
202610000
202520000
202400000
202310000
202200000
202100000
202000000
201900000
201820000
201700000

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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Novo Nordisk Pharmaceutical Industries LP Form 483s

1 Form 483 published by FDA.

DateDocumentFEI
Jul 13, 2023 · Document on fda.gov 4831000158576

A Form 483 lists the observations FDA investigators made at the end of an inspection. FDA publishes some Form 483s in its reading room, and each date links to that document. Read the observations with the FDA 483 search.

Recent FDA inspections

13 inspections from Sep 2, 2009 to Jun 30, 2026.

DateSiteProductClassificationFEI
Jun 30, 2026Petersburg, VADrugsNo Action Indicated (NAI)3033953703
Jul 30, 2025Durham, NCDrugsNo Action Indicated (NAI)3016799712
Jun 13, 2025Clayton, NCDrugsNo Action Indicated (NAI)1000158576
Dec 20, 2023Durham, NCDrugsNo Action Indicated (NAI)3016799712
Dec 20, 2018Durham, NCDrugsNo Action Indicated (NAI)3016799712
Jan 12, 2018Clayton, NCDrugsNo Action Indicated (NAI)1000158576
Dec 1, 2016Durham, NCDrugsNo Action Indicated (NAI)3016799712
Jan 28, 2016Clayton, NCDevicesNo Action Indicated (NAI)1000158576
Aug 21, 2014Clayton, NCDrugsNo Action Indicated (NAI)1000158576
Aug 16, 2012Clayton, NCDrugsNo Action Indicated (NAI)1000158576
Jul 1, 2011Clayton, NCDrugsNo Action Indicated (NAI)1000158576
Sep 3, 2010Clayton, NCDrugsNo Action Indicated (NAI)1000158576
Sep 2, 2009Clayton, NCDrugsVoluntary Action Indicated (VAI)1000158576
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

3 inspected sites, newest inspection first.

FacilityLocationInspectionsLatest
FEI 3033953703Petersburg, VA1Jun 30, 2026
FEI 3016799712Durham, NC4Jul 30, 2025
FEI 1000158576Clayton, NC8Jun 13, 2025

Novo Nordisk Pharmaceutical Industries LP and the FDA: common questions

Has Novo Nordisk Pharmaceutical Industries LP received an FDA warning letter?

No FDA warning letter addressed to the name "Novo Nordisk Pharmaceutical Industries LP" 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 Pharmaceutical Industries LP received an FDA Form 483?

FDA has published 1 Form 483 for Novo Nordisk Pharmaceutical Industries LP in its reading room, the most recent dated Jul 13, 2023. FDA publishes some Form 483s, not all of them.

When did the FDA last inspect Novo Nordisk Pharmaceutical Industries LP?

The most recent FDA inspection on file ended Jun 30, 2026 at Petersburg, VA and was classified NAI. FDA has 13 inspections of Novo Nordisk Pharmaceutical Industries LP on file.

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Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.