Novartis Pharmaceuticals Corporation
⚠️ High Risk
FEI: 2210396 • East Hanover, NJ • UNITED STATES
FEI Number
2210396
Location
East Hanover, NJ
Country
UNITED STATESAddress
1 Health Plz, , East Hanover, NJ, United States
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
NOT LISTED
It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).
AGR RX
The article appears to be a prescription drug manufactured in the U.S. and offered for import by other than the manufacturer and reimportation does not appear to have been authorized by the Secretary for use in a medical emergency.
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/5/2025 | 62ODA12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/28/2025 | 62ODA14AMLODIPINE BESYLATE (ANTI-HYPERTENSIVE, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/4/2025 | 58MCP25SECUKINUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/24/2024 | 58ACY04OMALIZUMAB | Division of Southeast Imports (DSEI) | |
| 3/28/2024 | 58MCY25SECUKINUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/30/2017 | 66VCO99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/3/2016 | 62OCE12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | Division of Northeast Imports (DNEI) | |
| 6/4/2012 | 66BCB19METHYLPHENIDATE HCL (STIMULANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/1/2011 | 64TAR99IMMUNOSUPPRESS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 12/1/2011 | 64TAR99IMMUNOSUPPRESS N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/30/2011 | 60LBY99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/29/2011 | 61VBA01SIMETHICONE (ANTI-FLATULENT) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/29/2011 | 62UAL11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/29/2011 | 62UAL11DEXTROMETHORPHAN HYDROBROMIDE (ANTI-TUSSIVE/COLD) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 1/26/2011 | 60LBL01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/26/2011 | 60LBL01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/26/2011 | 62MBY01CAMPHOR (ANTI-PRURITIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/26/2011 | 60LBL01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/10/2011 | 61VBA01SIMETHICONE (ANTI-FLATULENT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/29/2010 | 60LBA05ASPIRIN (ANALGESIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/29/2010 | 60LBA05ASPIRIN (ANALGESIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/29/2010 | 60LAY99ANALGESIC, N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/29/2010 | 60SBA07PRECIPITATED CALCIUM CARBONATE (ANTACID) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/29/2010 | 60LBA05ASPIRIN (ANALGESIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/29/2010 | 60LBA05ASPIRIN (ANALGESIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/29/2010 | 60LBA05ASPIRIN (ANALGESIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 11/29/2010 | 60LBA05ASPIRIN (ANALGESIC) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/26/2010 | 60LBL01ACETAMINOPHEN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/26/2010 | 60SBA07PRECIPITATED CALCIUM CARBONATE (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/26/2010 | 61WBQ31TOLNAFTATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/26/2010 | 60SBA07PRECIPITATED CALCIUM CARBONATE (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/16/2006 | 66NCL07OXCARBAZEPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 7/16/2006 | 60LCB14CARBAMAZEPINE (ANALGESIC) | 179AGR RX | New Orleans District Office (NOL-DO) |
| 5/15/2006 | 63XCA99DIAGOSTIC AID (DRUGS) N.E.C. | 179AGR RX | Cincinnati District Office (CIN-DO) |
| 11/4/2005 | 62COA12CYCLOPENTHIAZIDE (ANTI-HYPERTENSIVE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/25/2005 | 61WCP52TERBINAFINE HYDROCHLORIDE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/18/2005 | 55RP55SODIUM CHLORIDE (PHARMACEUTIC NECESSITY - TONICITY AGENT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/4/2005 | 62ODB43METOPROLOL SUCCINATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 1/6/2005 | 60LCP14CARBAMAZEPINE (ANALGESIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Novartis Pharmaceuticals Corporation's FDA import refusal history?
Novartis Pharmaceuticals Corporation (FEI: 2210396) has 39 FDA import refusal record(s) in our database, spanning from 1/6/2005 to 8/5/2025.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Novartis Pharmaceuticals Corporation's FEI number is 2210396.
What types of violations has Novartis Pharmaceuticals Corporation received?
Novartis Pharmaceuticals Corporation has been cited for 4 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about Novartis Pharmaceuticals Corporation come from?
All FDA import refusal data for Novartis Pharmaceuticals Corporation is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.