Novartis Farma Spa
⚠️ Moderate Risk
FEI: 3003662015 • Origgio, Varese • ITALY
FEI Number
3003662015
Location
Origgio, Varese
Country
ITALYAddress
20.5 233 Km, , Origgio, Varese, Italy
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
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 |
|---|---|---|---|
| 12/13/2011 | 62CCB99ANTI-HYPERTENSIVE N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 10/30/2009 | 62TCY04OCTREOTIDE ACETATE (ANTI-SECRETORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/18/2005 | 62ODB15BENAZEPRIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 118NOT LISTED | San Francisco District Office (SAN-DO) |
| 8/3/2005 | 60LDB14CARBAMAZEPINE (ANALGESIC) | Division of Southeast Imports (DSEI) | |
| 8/3/2005 | 60LDB14CARBAMAZEPINE (ANALGESIC) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Novartis Farma Spa's FDA import refusal history?
Novartis Farma Spa (FEI: 3003662015) has 5 FDA import refusal record(s) in our database, spanning from 8/3/2005 to 12/13/2011.
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 Farma Spa's FEI number is 3003662015.
What types of violations has Novartis Farma Spa received?
Novartis Farma Spa has been cited for 3 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 Farma Spa come from?
All FDA import refusal data for Novartis Farma Spa 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.