Novartis Pharmaceuticals
⚠️ Moderate Risk
FEI: 3001910153 • Surrey • UNITED KINGDOM
FEI Number
3001910153
Location
Surrey
Country
UNITED KINGDOMAddress
Frimley Business Parkfrimley, Camberley, , Surrey, , United Kingdom
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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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 |
|---|---|---|---|
| 1/16/2015 | 86MSISOLUTION, CLEANING/LUBRICATING, ARTICIFIAL EYE | New Orleans District Office (NOL-DO) | |
| 12/23/2014 | 61PCB99ANTI-DIABETIC N.E.C. | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 10/2/2007 | 64FDP24BROMOCRIPTINE MESYLATE (ENZYME INHIBITOR) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/21/2006 | 61JCB15EZETIMIBE | 75UNAPPROVED | New York District Office (NYK-DO) |
| 9/8/2005 | 62OAP15BENAZEPRIL HYDROCHLORIDE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/18/2005 | 62GDB18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Florida District Office (FLA-DO) |
| 3/31/2005 | 62GDB99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/15/2003 | 62TDB02LANSOPRAZOLE (ANTI-SECRETORY) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 4/15/2003 | 62GDY18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Novartis Pharmaceuticals's FDA import refusal history?
Novartis Pharmaceuticals (FEI: 3001910153) has 9 FDA import refusal record(s) in our database, spanning from 4/15/2003 to 1/16/2015.
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's FEI number is 3001910153.
What types of violations has Novartis Pharmaceuticals received?
Novartis Pharmaceuticals has been cited for 4 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 come from?
All FDA import refusal data for Novartis Pharmaceuticals 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.