Siegfried PharmaChemikalien Minden Gmbh
⚠️ Moderate Risk
FEI: 3002807400 • Minden, North Rhine-Westphalia • GERMANY
FEI Number
3002807400
Location
Minden, North Rhine-Westphalia
Country
GERMANYAddress
Karl Str. 15-39, , Minden, North Rhine-Westphalia, Germany
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).
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.
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).
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 |
|---|---|---|---|
| 11/3/2021 | 60CCS02DOPAMINE HCL (ADRENERGIC) | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 8/17/2021 | 60CAS48OXYMETAZOLINE HCL (ADRENERGIC) | Division of Southeast Imports (DSEI) | |
| 1/4/2019 | 63BCS30THEOPHYLLINE (BRONCHODILATOR) | 3280FRNMFGREG | Division of Southeast Imports (DSEI) |
| 1/19/2018 | 66BAR05CAFFEINE (STIMULANT) | 16DIRECTIONS | Division of Southeast Imports (DSEI) |
| 4/17/2013 | 60CAS10PSEUDOEPHEDRINE HCL (ADRENERGIC) | Division of Northeast Imports (DNEI) | |
| 11/28/2012 | 65QCS37AMINOPHYLLINE (RELAXANT) | New York District Office (NYK-DO) | |
| 11/28/2012 | 60CAS09PHENYLEPHRINE HCL (ADRENERGIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/20/2012 | 60CCS99ADRENERGIC N.E.C. | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 10/26/2012 | 65QCS37AMINOPHYLLINE (RELAXANT) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 8/14/2012 | 60CCS02DOPAMINE HCL (ADRENERGIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 3/21/2012 | 60CCS02DOPAMINE HCL (ADRENERGIC) | 75UNAPPROVED | Division of Northeast Imports (DNEI) |
| 1/18/2012 | 63BCS30THEOPHYLLINE (BRONCHODILATOR) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 8/31/2011 | 60CAS53XYLOMETAZOLINE HCL (ADRENERGIC) | 75UNAPPROVED | New York District Office (NYK-DO) |
| 11/15/2010 | 60CAS10PSEUDOEPHEDRINE HCL (ADRENERGIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 11/20/2008 | 66BAS05CAFFEINE (STIMULANT) | 118NOT LISTED | New York District Office (NYK-DO) |
| 3/28/2005 | 60CAS22EPHEDRINE HCL (ADRENERGIC) | New York District Office (NYK-DO) | |
| 10/4/2004 | 60CAS22EPHEDRINE HCL (ADRENERGIC) | 16DIRECTIONS | New York District Office (NYK-DO) |
| 9/26/2004 | 66SCS99VASODILATOR N.E.C. | 16DIRECTIONS | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Siegfried PharmaChemikalien Minden Gmbh's FDA import refusal history?
Siegfried PharmaChemikalien Minden Gmbh (FEI: 3002807400) has 18 FDA import refusal record(s) in our database, spanning from 9/26/2004 to 11/3/2021.
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 PharmaChemikalien Minden Gmbh's FEI number is 3002807400.
What types of violations has Siegfried PharmaChemikalien Minden Gmbh received?
Siegfried PharmaChemikalien Minden Gmbh 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 Siegfried PharmaChemikalien Minden Gmbh come from?
All FDA import refusal data for Siegfried PharmaChemikalien Minden 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.