Novartis Nutrition AG
⚠️ Moderate Risk
FEI: 3004437293 • Bern, Bern • SWITZERLAND
FEI Number
3004437293
Location
Bern, Bern
Country
SWITZERLANDAddress
Monbijoustrasse 118, , Bern, Bern, 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/21/2018 | 62GBY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/28/2015 | 65DCQ06OXYTOCIN (INJECTION) (OXYTOCIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/26/2013 | 65VCA13CLOZAPINE (SEDATIVE) | 75UNAPPROVED | Detroit District Office (DET-DO) |
| 11/21/2011 | 62GCP90DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 1/4/2011 | 61PCY60NATEGLINIDE (ANTI-DIABETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/25/2009 | 60CBQ53XYLOMETAZOLINE HCL (ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/30/2007 | 60CCO09PHENYLEPHRINE HCL (ADRENERGIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/1/2006 | 61LBO14CHLORHEXIDINE GLUCONATE | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/1/2006 | 62GBO90DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/1/2006 | 62GBO18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 8/22/2006 | 61DCP01CINEPAZET MALEATE (ANTI-ANGINAL) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 6/28/2005 | 62GCA99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/23/2005 | 64BCY25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/30/2005 | 61CDA99ANTI-ANEMIC, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/24/2005 | 61WAY52TERBINAFINE HYDROCHLORIDE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 12/8/2003 | 62UDK99ANTI-TUSSIVE/COLD N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Novartis Nutrition AG's FDA import refusal history?
Novartis Nutrition AG (FEI: 3004437293) has 16 FDA import refusal record(s) in our database, spanning from 12/8/2003 to 8/21/2018.
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 Nutrition AG's FEI number is 3004437293.
What types of violations has Novartis Nutrition AG received?
Novartis Nutrition AG 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 Nutrition AG come from?
All FDA import refusal data for Novartis Nutrition 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.