Froximun Ag
⚠️ High Risk
FEI: 3005695967 • Schlanstedt, Saxony-Anhalt • GERMANY
FEI Number
3005695967
Location
Schlanstedt, Saxony-Anhalt
Country
GERMANYAddress
Neue Str. 2a, , Schlanstedt, Saxony-Anhalt, Germany
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
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.
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).
FALSE
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/11/2025 | 54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 2/24/2025 | 54YCR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 260FALSE | Division of Northern Border Imports (DNBI) |
| 2/24/2025 | 54YCE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 260FALSE | Division of Northern Border Imports (DNBI) |
| 1/14/2025 | 78QUNTETHER ACCESSORY FOR USE IN THE GASTROINTESTINAL TRACT | Division of Southeast Imports (DSEI) | |
| 8/27/2024 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 8/5/2024 | 41YYY99DIETARY CONVENTIONAL FOODS, N.E.C. | Division of Southeast Imports (DSEI) | |
| 4/30/2024 | 54BCH08MAGNESIUM (MINERAL) | Division of Southeast Imports (DSEI) | |
| 4/30/2024 | 54BCZ08MAGNESIUM (MINERAL) | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Froximun Ag's FDA import refusal history?
Froximun Ag (FEI: 3005695967) has 8 FDA import refusal record(s) in our database, spanning from 4/30/2024 to 7/11/2025.
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. Froximun Ag's FEI number is 3005695967.
What types of violations has Froximun Ag received?
Froximun Ag has been cited for 5 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 Froximun Ag come from?
All FDA import refusal data for Froximun 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.