Novartis International Ag
⚠️ Moderate Risk
FEI: 3001059001 • Basel, Basel Stadt • SWITZERLAND
FEI Number
3001059001
Location
Basel, Basel Stadt
Country
SWITZERLANDAddress
Mattenstrasse 22, , Basel, Basel Stadt, 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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/5/2010 | 62GCY90DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 11/22/2006 | 60LCE99ANALGESIC, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/1/2006 | 61NCY99ANTI-DEPRESSANT N.E.C. | Florida District Office (FLA-DO) | |
| 2/16/2006 | 68YIS20ANIMAL DRUGS N.E.C. USED MORE THAN 1 SPECIES | 72NEW VET DR | New Orleans District Office (NOL-DO) |
| 10/21/2005 | 61JCA10FLUVASTATIN SODIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/23/2005 | 62LCA99ANTI-PROTOZOAL, ANTI-LEISHMANIAL, ANTI-MALARIAL, N.E.C. | New York District Office (NYK-DO) | |
| 4/6/2005 | 62CDA99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/7/2005 | 62CDB99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/7/2005 | 62IIS99ANTI-NEOPLASTIC N.E.C. | 16DIRECTIONS | New York District Office (NYK-DO) |
| 3/3/2005 | 62IIS99ANTI-NEOPLASTIC N.E.C. | New York District Office (NYK-DO) | |
| 4/12/2004 | 65ADB03TACRINE HYDROCHLORIDE (MEMORY ADJUVANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/3/2004 | 60ECA02AMINOGLUTETHIMIDE (ADRENOCORTICAL SUPPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/25/2003 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Novartis International Ag's FDA import refusal history?
Novartis International Ag (FEI: 3001059001) has 13 FDA import refusal record(s) in our database, spanning from 7/25/2003 to 3/5/2010.
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 International Ag's FEI number is 3001059001.
What types of violations has Novartis International Ag received?
Novartis International Ag has been cited for 5 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 International Ag come from?
All FDA import refusal data for Novartis International 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.