Atlas

FDA-Inspected Site

Novartis Pharmaceuticals Corporation

41 FDA inspections are on record for Novartis Pharmaceuticals Corporation in East Hanover, United States.

Clean· No action indicated

East Hanover, United States · Last updated July 10, 2026

Overview

  • 41 FDA inspections are on record.
  • 10 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-06-25.

At a glance

Inspections

41

Form 483s

10

EIRs

3

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
23 Jun 2025 – 25 Jun 2025Human DrugsClean
26 Feb 2025 – 3 Mar 2025Human DrugsClean
12 Nov 2024 – 19 Nov 2024Human DrugsClean
26 Aug 2024 – 29 Aug 2024Human DrugsClean
24 Jun 2024 – 27 Jun 2024Human DrugsClean
7 Aug 2023 – 21 Aug 2023Human Drugs483View 483 →
5 Jun 2023 – 13 Jun 2023Human DrugsClean
29 Jun 2021 – 9 Jul 2021Human DrugsClean
24 Feb 2021 – 3 Mar 2021Human DrugsClean
22 Jun 2020 – 2 Jul 2020Human DrugsClean
19 Jun 2019 – 2 Jul 2019Human Drugs483View 483 →
13 Feb 2019 – 21 Feb 2019Human DrugsClean

Observations on record

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

21 Aug 2023
21 CFR 312.50

General responsibilities of sponsors

Cited by Tyanna N Hadley, Mayar M Mussa

2 Jul 2019
21 CFR 312.50

General responsibilities of sponsors

Cited by Nina Yang, Shirley S Wen

2 Jul 2019
21 CFR 312.50

General responsibilities of sponsors

Cited by Nina Yang, Shirley S Wen

14 Dec 2018
21 CFR 312.50

General responsibilities of sponsors

Cited by Peter R Lenahan, Kassa Ayalew, Cheryl A Grandinetti

24 Jan 2017
21 CFR 312.50

General responsibilities of sponsors

Cited by Nina Yang, Peter R Lenahan

Investigators

FDA investigators tied to this site in the record.

Peter R Lenahan10 insp.
Nina Yang5 insp.
Michael Serrano4 insp.
Christina N Maurino4 insp.
Mayar M Mussa2 insp.
Denise M Visco2 insp.
Douglas C Kovacs2 insp.
Kellie R Riggs1 insp.
Matthew R Coleman1 insp.
Helen Verdel1 insp.
Leon L Crawley1 insp.
Tyanna N Hadley1 insp.
Shirley S Wen1 insp.
Kassa Ayalew1 insp.
Cheryl A Grandinetti1 insp.
Tonia F Bernard1 insp.
Yvesna C Blaise1 insp.
Melissa T Roy1 insp.
Guerlain Ulysse1 insp.
Emmanuel J Ramos1 insp.
Lata C Mathew1 insp.
Liatte Krueger1 insp.
Charles Chacko1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 312.50Cited across public-safe Form 483 observations9x
21 CFR 312.56(b)Cited across public-safe Form 483 observations2x
21 CFR 312.55(b)Cited across public-safe Form 483 observations1x
21 CFR 312.56(a)Cited across public-safe Form 483 observations1x
21 CFR 312.56(c)Cited across public-safe Form 483 observations1x
21 CFR 312.57(c)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Novartis Pharmaceuticals Corporation's 10 Form 483s

Source PDFs, verbatim observations, 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