Atlas

FDA-Inspected Site

Novo Nordisk Pharmaceutical Industries LP

3 FDA inspections are on record for Novo Nordisk Pharmaceutical Industries LP in Durham, United States.

Clean· No action indicated

Durham, United States · Last updated July 11, 2026

Overview

  • 3 FDA inspections are on record.
  • 1 inspection produced a Form 483.
  • The most recent recorded inspection date is 2025-07-30.

At a glance

Inspections

3

Form 483s

1

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
28 Jul 2025 – 30 Jul 2025Human DrugsClean
20 Aug 2024 – 29 Aug 2024Human Drugs483View 483 →
18 Dec 2023 – 20 Dec 2023Human DrugsClean

Observations on record

Form 483 observations cited at this site, most recent first.

29 Aug 2024
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Simone E Pitts, Marian E Ramirez, James Norman, Chunsheng Cai, Sarah C Zimmermann

29 Aug 2024
21 CFR 211.111

Establishment of time limitations

Cited by Simone E Pitts, Marian E Ramirez, James Norman, Chunsheng Cai, Sarah C Zimmermann

29 Aug 2024
21 CFR 211.142(b)

Storage under appropriate conditions

Cited by Simone E Pitts, Marian E Ramirez, James Norman, Chunsheng Cai, Sarah C Zimmermann

29 Aug 2024
21 CFR 211.166(a)

Lack of written stability program

Cited by Simone E Pitts, Marian E Ramirez, James Norman, Chunsheng Cai, Sarah C Zimmermann

29 Aug 2024
21 CFR 211.22(a)

Approve or reject components, products

Cited by Simone E Pitts, Marian E Ramirez, James Norman, Chunsheng Cai, Sarah C Zimmermann

Investigators

FDA investigators tied to this site in the record.

Nicole E Knowlton1 insp.
Simone E Pitts1 insp.
Marian E Ramirez1 insp.
James Norman1 insp.
Chunsheng Cai1 insp.
Sarah C Zimmermann1 insp.
Susan O Oladeji1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.111Cited across public-safe Form 483 observations1x
21 CFR 211.142(b)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.46(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Novo Nordisk Pharmaceutical Industries LP's 1 Form 483

Source PDFs and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat