Sandoz GmbH
⚠️ High Risk
FEI: 3002806523 • Kundl, Tyrol • AUSTRIA
FEI Number
3002806523
Location
Kundl, Tyrol
Country
AUSTRIAAddress
Biochemiestrase 10, , Kundl, Tyrol, Austria
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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).
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.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/3/2025 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/7/2024 | 58MDY25SECUKINUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/3/2024 | 58MCN25SECUKINUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/13/2024 | 58MDL25SECUKINUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/24/2024 | 58MCK25SECUKINUMAB | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/5/2021 | 56CCA71CEFUROXIME AXETIL (CEPHALOSPORINS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/15/2018 | 56ICR76AZITHROMYCIN (MACAROLIDES) | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/23/2017 | 56BDY07AMPICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/20/2017 | 64RIN99HORMONE N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 5/24/2017 | 61WAJ48NAFTIFINE HYDROCHLORIDE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | Division of Northeast Imports (DNEI) | |
| 10/21/2016 | 56BCA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/12/2012 | 56BCY10BENZYLPENICILLOYL-POLYLYSINE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/29/2009 | 56BBA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 5/23/2007 | 56BCK10BENZYLPENICILLOYL-POLYLYSINE (PENICILLIN, SYNTHETICALLY PRODUCED) | Cincinnati District Office (CIN-DO) | |
| 3/29/2006 | 66JCS01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/15/2005 | 56BDA03AMOXICILLIN TRIHYDRATE (PENICILLIN, SYNTHETICALLY PRODUCED) | New York District Office (NYK-DO) | |
| 9/15/2005 | 61HCN99ANTI-BACTERIAL, N.E.C. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 3/23/2005 | 61FIR56CLARITHROMYCIN (ANTI-BACTERIAL PART I) (NOT ANTIBIOTIC) | New York District Office (NYK-DO) | |
| 2/1/2005 | 66VIY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New York District Office (NYK-DO) |
| 7/30/2004 | 80FMFSYRINGE, PISTON | 341REGISTERED | New York District Office (NYK-DO) |
| 7/30/2004 | 56CCA65CEFPROZIL (CEPHALOSPORINS) | New York District Office (NYK-DO) | |
| 7/30/2004 | 56CCR99CEPHALOSPORIN N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Sandoz GmbH's FDA import refusal history?
Sandoz GmbH (FEI: 3002806523) has 22 FDA import refusal record(s) in our database, spanning from 7/30/2004 to 4/3/2025.
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. Sandoz GmbH's FEI number is 3002806523.
What types of violations has Sandoz GmbH received?
Sandoz GmbH has been cited for 8 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 Sandoz GmbH come from?
All FDA import refusal data for Sandoz GmbH 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.