Steigerwald Arzneimittelwerk Gmbh
⚠️ Moderate Risk
FEI: 3002594201 • Darmstadt, Hassia • GERMANY
FEI Number
3002594201
Location
Darmstadt, Hassia
Country
GERMANYAddress
Havelstr. 5, , Darmstadt, Hassia, 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
HEALTH C
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
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).
NUTRIT LBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.
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).
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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 |
|---|---|---|---|
| 3/22/2017 | 66VB99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 5/27/2010 | 54FCL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Cincinnati District Office (CIN-DO) | |
| 5/26/2010 | 54FCL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Cincinnati District Office (CIN-DO) | |
| 7/5/2006 | 54FEL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Steigerwald Arzneimittelwerk Gmbh's FDA import refusal history?
Steigerwald Arzneimittelwerk Gmbh (FEI: 3002594201) has 4 FDA import refusal record(s) in our database, spanning from 7/5/2006 to 3/22/2017.
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. Steigerwald Arzneimittelwerk Gmbh's FEI number is 3002594201.
What types of violations has Steigerwald Arzneimittelwerk Gmbh received?
Steigerwald Arzneimittelwerk Gmbh has been cited for 7 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 Steigerwald Arzneimittelwerk Gmbh come from?
All FDA import refusal data for Steigerwald Arzneimittelwerk 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.