Novartis Pharma Gmbh
⚠️ High Risk
FEI: 3002532211 • Nuremberg, Bavaria • GERMANY
FEI Number
3002532211
Location
Nuremberg, Bavaria
Country
GERMANYAddress
Roonstr. 25, , Nuremberg, Bavaria, Germany
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.
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/21/2025 | 58ACP04OMALIZUMAB | Division of Southeast Imports (DSEI) | |
| 12/30/2024 | 58ACK04OMALIZUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/21/2016 | 62ODB12VALSARTAN (ANTI-HYPERTENSIVE - PART II) | Division of Northern Border Imports (DNBI) | |
| 10/30/2009 | 60HAK99ALDOSTERONE ANTAGONIST, N.E.C. | New Orleans District Office (NOL-DO) | |
| 2/7/2008 | 64GAB07ESTRADIOL (ESTROGEN) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/27/2006 | 61LIS38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/7/2006 | 62GAJ18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/5/2005 | 61MCA99ANTI-CONVULSANT, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/25/2004 | 60LCJ99ANALGESIC, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Novartis Pharma Gmbh's FDA import refusal history?
Novartis Pharma Gmbh (FEI: 3002532211) has 9 FDA import refusal record(s) in our database, spanning from 2/25/2004 to 11/21/2025.
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 Pharma Gmbh's FEI number is 3002532211.
What types of violations has Novartis Pharma Gmbh received?
Novartis Pharma Gmbh has been cited for 6 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 Gmbh come from?
All FDA import refusal data for Novartis Pharma Gmbh 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.