Novartis Pharma Produktions GmbH
⚠️ High Risk
FEI: 3000978864 • Wehr, Baden-Wurttemberg • GERMANY
FEI Number
3000978864
Location
Wehr, Baden-Wurttemberg
Country
GERMANYAddress
Oflinger Str. 44, , Wehr, Baden-Wurttemberg, 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).
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.
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.
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 |
|---|---|---|---|
| 1/14/2025 | 58ACY04OMALIZUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/22/2024 | 61PDA55METFORMIN HCL (ANTI-DIABETIC) | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 9/20/2024 | 61PDA26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/17/2024 | 61PCA26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/30/2023 | 61PCB26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/3/2021 | 61PDA26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/3/2020 | 64TCA04MYCOPHENOLATE MOFETIL (IMMUNOSUPPRESSIVE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/23/2017 | 62GAL18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Northeast Imports (DNEI) | |
| 11/21/2016 | 61PCY26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/18/2016 | 62GBO18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/1/2006 | 62GCO18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/7/2006 | 62VDO35PENCICLOVIR (ANTI-VIRAL) | 118NOT LISTED | New York District Office (NYK-DO) |
| 7/7/2006 | 62VDO35PENCICLOVIR (ANTI-VIRAL) | 118NOT LISTED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Novartis Pharma Produktions GmbH's FDA import refusal history?
Novartis Pharma Produktions GmbH (FEI: 3000978864) has 13 FDA import refusal record(s) in our database, spanning from 7/7/2006 to 1/14/2025.
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 Produktions GmbH's FEI number is 3000978864.
What types of violations has Novartis Pharma Produktions GmbH received?
Novartis Pharma Produktions GmbH 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 Pharma Produktions GmbH come from?
All FDA import refusal data for Novartis Pharma Produktions 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.