Siegfried AG
⚠️ Moderate Risk
FEI: 3002808158 • Zofingen, Aargau • SWITZERLAND
FEI Number
3002808158
Location
Zofingen, Aargau
Country
SWITZERLANDAddress
Untere Bruhlstrasse 4, , Zofingen, Aargau, 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
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.
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 |
|---|---|---|---|
| 12/3/2015 | 66BDS44NICOTINE DELIVERY SYSTEM | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 8/10/2015 | 66BIY44NICOTINE DELIVERY SYSTEM | 16DIRECTIONS | Philadelphia District Office (PHI-DO) |
| 11/14/2014 | 66BDS44NICOTINE DELIVERY SYSTEM | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 9/12/2014 | 66BDS44NICOTINE DELIVERY SYSTEM | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/11/2014 | 60QDS78PROPARACAINE HCL (ANESTHETIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 3/11/2014 | 60QIS78PROPARACAINE HCL (ANESTHETIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 1/19/2012 | 61MCS13MEPHOBARBITAL (ANTI-CONVULSANT) | 118NOT LISTED | Baltimore District Office (BLT-DO) |
| 1/19/2012 | 61MCS13MEPHOBARBITAL (ANTI-CONVULSANT) | 118NOT LISTED | Baltimore District Office (BLT-DO) |
| 10/28/2010 | 61MCS13MEPHOBARBITAL (ANTI-CONVULSANT) | Philadelphia District Office (PHI-DO) | |
| 10/28/2010 | 61MCS13MEPHOBARBITAL (ANTI-CONVULSANT) | Philadelphia District Office (PHI-DO) | |
| 6/16/2005 | 62GIR99ANTI-INFLAMMATORY N.E.C. | New York District Office (NYK-DO) | |
| 3/2/2005 | 63NCS03BETHANECHOL CHLORIDE (CHOLINERGIC) | 75UNAPPROVED | Philadelphia District Office (PHI-DO) |
| 2/13/2002 | 61MCS25PRIMIDONE (ANTI-CONVULSANT) | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Siegfried AG's FDA import refusal history?
Siegfried AG (FEI: 3002808158) has 13 FDA import refusal record(s) in our database, spanning from 2/13/2002 to 12/3/2015.
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. Siegfried AG's FEI number is 3002808158.
What types of violations has Siegfried AG received?
Siegfried AG 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 Siegfried AG come from?
All FDA import refusal data for Siegfried 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.