Novartis Pharma Stein AG

🚨 Critical Risk

FEI: 3002653483 • Stein Ag, Aargau • SWITZERLAND

FEI

FEI Number

3002653483

📍

Location

Stein Ag, Aargau

🇨🇭

Country

SWITZERLAND

🏢

Address

Schaffhauserstrasse 101, , Stein Ag, Aargau, Switzerland

Critical Risk

FDA Import Risk Assessment

76.5

LowModerateHighCritical

This firm has an extensive history of FDA import refusals with severe violations.

Statistics

Total Refusals

Unique Violations

9/3/2025

Latest Refusal

8/17/2004

Earliest Refusal

Score Breakdown

Violation Severity

79.8×40%

Refusal Volume

72.6×30%

Recency

92.9×20%

Frequency

42.7×10%

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

Violation Summary

7584×

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).

1667×

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.

1184×

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).

32801×

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.

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

721×

NEW VET DR

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.

Refusal History

Date	Product	Violations	Division
9/3/2025	58MCY25SECUKINUMAB	75UNAPPROVED	Division of Northeast Imports (DNEI)
9/21/2023	64TCS99IMMUNOSUPPRESS N.E.C.	118NOT LISTED	Division of West Coast Imports (DWCI)
5/23/2017	62GDK18DICLOFENAC SODIUM (ANTI-INFLAMMATORY)	118NOT LISTED 16DIRECTIONS 3280FRNMFGREG 472NO ENGLISH	Division of Northeast Imports (DNEI)
5/23/2016	66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	Florida District Office (FLA-DO)
5/23/2016	66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	Florida District Office (FLA-DO)
3/10/2015	60LCY14CARBAMAZEPINE (ANALGESIC)	75UNAPPROVED	Cincinnati District Office (CIN-DO)
1/7/2015	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	Division of Northeast Imports (DNEI)
1/7/2015	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	Division of Northeast Imports (DNEI)
4/15/2013	66VCE99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	Division of Northeast Imports (DNEI)
4/15/2013	66VCE99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	Division of Northeast Imports (DNEI)
1/18/2012	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	New York District Office (NYK-DO)
1/18/2012	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	New York District Office (NYK-DO)
11/22/2011	62ALP99ANTI-HYPERCALCEMIC N.E.C.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/22/2011	62ALP99ANTI-HYPERCALCEMIC N.E.C.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
11/4/2011	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	16DIRECTIONS 75UNAPPROVED	New York District Office (NYK-DO)
1/7/2011	64TIS09IMATINIB MESYLATE (IMMUNOSUPPRESSIVE)	75UNAPPROVED	New Orleans District Office (NOL-DO)
7/1/2010	61WAS52TERBINAFINE HYDROCHLORIDE (ANTI-FUNGAL) (NOT ANTIBIOTIC)	16DIRECTIONS	New York District Office (NYK-DO)
10/6/2009	68YYY99OTHER ANIMAL, N.E.C. ANIMAL DRUGS N.E.C.	72NEW VET DR	New Orleans District Office (NOL-DO)
8/19/2008	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	New York District Office (NYK-DO)
7/10/2008	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	New York District Office (NYK-DO)
8/17/2006	61MCS99ANTI-CONVULSANT, N.E.C.	118NOT LISTED 16DIRECTIONS	New York District Office (NYK-DO)
7/14/2006	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	New York District Office (NYK-DO)
7/14/2006	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	New York District Office (NYK-DO)
7/14/2006	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	New York District Office (NYK-DO)
7/14/2006	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	New York District Office (NYK-DO)
7/14/2006	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	New York District Office (NYK-DO)
7/14/2006	66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	New York District Office (NYK-DO)
4/17/2006	62OCY12VALSARTAN (ANTI-HYPERTENSIVE - PART II)	118NOT LISTED	San Francisco District Office (SAN-DO)
8/17/2004	62GIK89CYCLOSPORINE (ANTI-INFLAMMATORY)	75UNAPPROVED	New York District Office (NYK-DO)

Frequently Asked Questions

What is Novartis Pharma Stein AG's FDA import refusal history?

Novartis Pharma Stein AG (FEI: 3002653483) has 90 FDA import refusal record(s) in our database, spanning from 8/17/2004 to 9/3/2025.

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 Stein AG's FEI number is 3002653483.

What types of violations has Novartis Pharma Stein AG received?

Novartis Pharma Stein AG has been cited for 6 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 Stein AG come from?

All FDA import refusal data for Novartis Pharma Stein 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.