Novo Nordisk Inc.

FDA establishment 2244771, Plainsboro, New Jersey, United States. Part of Novo Nordisk's FDA records. Every inspection FDA has posted for the site, with its outcome and cited regulations, and the shipments FDA refused at the border.

Inspections: 10
Official action indicated: 1
Last inspection ended: Feb 7, 2025
Warning letters: 2
Import refusals since 2024: 8

Inspections by Fiscal Year

FY2018 to FY2027 to date; 1 classified OAI

How to read this

A hatched bar is a year that is not over, so its count covers only part of the year.

02019

02021

12023

12025

02027

Most Cited at This Site

Inspections citing each reference

21 CFR 314.80(c)(1)(ii): Failure to investigate serious, unexpected events1
21 CFR 314.80(c)(2)(ii)(B): Late submission of an ICSR1
21 CFR 314.80(c)(1)(i): Late submission of 15-day report1
21 CFR 314.80(b): Failure to develop written procedures1
21 CFR 312.50: General responsibilities of sponsors1

Inspections

10 inspections, newest first

Ended	Product and area	Citations	Classification
Feb 7, 2025	Drugs · Bioresearch Monitoring	4 cited references 21 CFR 314.80(c)(1)(ii). Failure to investigate serious, unexpected events Adverse drug experiences that were the subject of post marketing 15-day reports were not investigated. 21 CFR 314.80(c)(2)(ii)(B). Late submission of an ICSR You failed to submit an ICSR for the reporting period. 21 CFR 314.80(c)(1)(i). Late submission of 15-day report Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information. 21 CFR 314.80(b). Failure to develop written procedures Written procedures have not been developed for the surveillance, receipt and reporting to FDA of post marketing adverse drug experiences.	Official Action Indicated (OAI)
Dec 21, 2022	Drugs · Bioresearch Monitoring	None posted	No Action Indicated (NAI)
Apr 13, 2017	Drugs · Bioresearch Monitoring	1 cited reference 21 CFR 312.50. General responsibilities of sponsors Failure to ensure proper monitoring of the study.	Voluntary Action Indicated (VAI)
Jul 22, 2016	Devices · Postmarket Assurance: DevicesDevices · Compliance: Devices	None posted	No Action Indicated (NAI)
Apr 12, 2016	Drugs · Bioresearch Monitoring	None posted	No Action Indicated (NAI)
Jun 19, 2014	Drugs · Bioresearch Monitoring	None posted	No Action Indicated (NAI)
Apr 15, 2014	Drugs · Bioresearch Monitoring	None posted	No Action Indicated (NAI)
Apr 3, 2012	Drugs · Bioresearch Monitoring	None posted	No Action Indicated (NAI)
Sep 28, 2009	Drugs · Bioresearch MonitoringDrugs · Drug Quality Assurance	None posted	No Action Indicated (NAI)
Dec 11, 2008	Drugs · Bioresearch Monitoring	None posted	No Action Indicated (NAI)

Warning Letters

Letters naming this establishment; each opens the letter

CAPAMar 5, 2026
DrugsSep 9, 2025

Import Refusals

8 refused shipment lines since 2024, grouped by product and charges

Product	Charges	Latest
SEMAGLUTIDE (ANTI-DIABETIC)Drugs · 61PCL72	Unapproved new drug	Jun 22, 20263 lines
SEMAGLUTIDE (ANTI-DIABETIC)Drugs · 61PDY72	Unapproved new drug	Jun 27, 2025
SEMAGLUTIDE (ANTI-DIABETIC)Drugs · 61PCY72	Unapproved new drug	Jun 2, 20253 lines
INSULIN (INJ) (ANTI-DIABETIC)Drugs · 61PCK17	Unapproved new drug	May 13, 2024

Identifiers

FEI number: 2244771
FDA firm profile: Data Dashboard
Company: Novo Nordisk

An FEI (FDA Establishment Identifier) names one physical site. Inspections, outcomes and citations come from FDA's Data Dashboard; FDA posts citations only for some inspections. A contract site can make products for many companies, so the company shown is the one FDA lists as the site's firm. FDA Data Dashboard and warning letters