Novartis Pharma Ag
⚠️ Moderate Risk
FEI: 3000189692 • Basel Town, Basel Town • SWITZERLAND
FEI Number
3000189692
Location
Basel Town, Basel Town
Country
SWITZERLANDAddress
Klybeckstrasse 141, , Basel Town, Basel Town, Switzerland
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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).
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 |
|---|---|---|---|
| 5/19/2020 | 61KDQ99ANTI-CHOLINERGIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/18/2020 | 62ODA12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 5/4/2020 | 62GDY90DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/26/2019 | 66NCY07OXCARBAZEPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/11/2018 | 62GCO18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/11/2018 | 66YDB99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Division of Southeast Imports (DSEI) | |
| 5/4/2018 | 61PCA99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/12/2017 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 1/12/2017 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 9/6/2016 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 7/13/2016 | 61NCB11CLOMIPRAMINE HCL (ANTI-DEPRESSANT) | 118NOT LISTED | Florida District Office (FLA-DO) |
| 5/27/2016 | 66YIH99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 8/13/2015 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 1/7/2012 | 60CCQ53XYLOMETAZOLINE HCL (ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/5/2011 | 64TDE09IMATINIB MESYLATE (IMMUNOSUPPRESSIVE) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/20/2009 | 61WBA52TERBINAFINE HYDROCHLORIDE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/20/2009 | 61WBO52TERBINAFINE HYDROCHLORIDE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 11/20/2008 | 68YCH10SMALL ANIMAL ANIMAL DRUGS N.E.C. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/1/2006 | 65UCP02TRIBENOSIDE (SCLEROSING AGENT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 4/20/2005 | 66VIR99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/18/2005 | 61HIR99ANTI-BACTERIAL, N.E.C. | New York District Office (NYK-DO) | |
| 2/22/2005 | 61HIR99ANTI-BACTERIAL, N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Novartis Pharma Ag's FDA import refusal history?
Novartis Pharma Ag (FEI: 3000189692) has 22 FDA import refusal record(s) in our database, spanning from 2/22/2005 to 5/19/2020.
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 Pharma Ag's FEI number is 3000189692.
What types of violations has Novartis Pharma Ag received?
Novartis Pharma Ag has been cited for 3 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 Pharma Ag come from?
All FDA import refusal data for Novartis Pharma Ag 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.