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•United States

Novartis Pharmaceuticals Corporation, Morris Plains, NJ – FDA Inspections

Inspection records and compliance data for Novartis Pharmaceuticals Corporation in Morris Plains, NJ. 5 FDA inspections on record, 3 Form 483s, last inspected February 06, 2026.

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Company Profile

This profile covers Novartis Pharmaceuticals Corporation based in Morris Plains, NJ, United States.

FDA Inspection History

FDA inspections
5
OAI
0
VAI
2
NAI
1
Unclassified
2
Form 483s
3
Warning letters
0

First inspected April 7, 2017. Last inspected February 6, 2026.

Most cited issue areas

  • Procedures for sterile drug products3 inspections
  • Cleaning / Sanitizing / Maintenance1 inspection
  • Computer control of master formula records1 inspection

FDA inspections (5)

DateResultFDA center(s)Insp. #
February 6, 2026Not classifiedBiologics · Human Cellular, Tissue, and Gene Therapies1300144
August 8, 2024VAIBiologics · Human Cellular, Tissue, and Gene Therapies1245942
December 9, 2022NAIBiologics · Vaccines and Allergenic Products1194474
August 21, 2019VAIBiologics · Human Cellular, Tissue, and Gene Therapies1100101
April 7, 2017Not classifiedBiologics1019194
FDA documents

Form 483s (5)

  • Form 483s · February 6, 2026
  • Form 483s · August 8, 2024
  • Form 483s · December 9, 2022
  • Form 483s · August 21, 2019
  • Form 483s

Warning Letters (1)

  • Warning Letters · August 8, 2023

EIRs (2)

  • EIRs · August 21, 2019
  • EIRs · April 7, 2017
Other regulators (1)
  • UK MHRA · 2 inspections · last April 22, 2013
People (6)
Xiaobin (Victor) Lu
Person
Joan Johnson
Person
Susan M. Jackson
Person
Colleen Hoyt
Person
Kimberly L. Schultz
Person
Jacqueline M. Diaz Albertini
Person
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Company Information

Name

Novartis Pharmaceuticals Corporation

FEI Number

3010353512

Address

220 East Hanover Ave., Morris Plains, NJ 07950, United States

Country

United States

ID: 21559fd5-35ed-4cbd-b228-623dd76bcf47

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