NOVARTIS PHARMACEUTICALS N2
⚠️ Moderate Risk
FEI: 3014511679 • Auckland • NEW ZEALAND
FEI Number
3014511679
Location
Auckland
Country
NEW ZEALANDAddress
109 Carlton Gore Road, , Auckland, , New Zealand
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
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/9/2022 | 66RDB01ANGIOTENSIN AMIDE (VASOCONSTRICTOR) | Division of West Coast Imports (DWCI) | |
| 2/9/2022 | 61PDB09GLIPIZIDE (ANTI-DIABETIC) | Division of West Coast Imports (DWCI) | |
| 2/9/2022 | 61PDB55METFORMIN HCL (ANTI-DIABETIC) | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is NOVARTIS PHARMACEUTICALS N2's FDA import refusal history?
NOVARTIS PHARMACEUTICALS N2 (FEI: 3014511679) has 3 FDA import refusal record(s) in our database, spanning from 2/9/2022 to 2/9/2022.
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 N2's FEI number is 3014511679.
What types of violations has NOVARTIS PHARMACEUTICALS N2 received?
NOVARTIS PHARMACEUTICALS N2 has been cited for 2 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 N2 come from?
All FDA import refusal data for NOVARTIS PHARMACEUTICALS N2 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.